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NCT05710406Active, not recruitingPhase 2/3

Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer

Source: ClinicalTrials.gov · Last updated 2 Jul 2026

Brief summary (registry, in English)

This phase II/III trial compares the effect of the combination of encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab combination after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
1 (actual)
First submitted
24 Jan 2023
Start date
16 Aug 2023
Primary completion date
1 Jun 2034
Lead sponsor
Alliance for Clinical Trials in Oncology
NCT number
NCT05710406

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 1
  • From 16 Aug 2023 to the primary completion date, 1 Jun 2034
  • 202 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • PRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA:
  • Pre-registration for central tumor testing will occur after colon resection. Pre-registration can occur at any time after surgery through a twelve week period after completion of standard adjuvant therapy
  • BRAF V600 mutational status may be determined either locally or by central testing. This testing is mandatory prior to registration to determine eligibility. Tissue submission should be initiated as soon after surgery as possible. For tumors evaluated at local laboratories, formalin-fixed paraffin-embedded (FFPE) tumor tissue must still be submitted for central confirmation of BRAF status
  • REGISTRATION (STEP 1) ELIGIBILITY CRITERIA:
  • Histologically-proven stage III (any T \[Tx, T1, T2, T3, or T4\], N1-2M0; includes N1C) or high-risk (pT4) stage II colon adenocarcinoma. Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve) and must have been completely resected
  • BRAF V600E mutation
  • MMR proficient (pMMR) or microsatellite stable (MSS) tumor
  • Histologic documentation: adenocarcinoma
  • Stage: III (any T \[Tx, T1, T2, T3, or T4\], N1-2M0; includes N1C) or high-risk II (pT4)
  • Tumor site: colon
  • Patients must have received at least 3 months of adjuvant chemotherapy with either leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) (minimum of 5 cycles) or capecitabine and oxaliplatin (CAPOX) (minimum of 3 cycles)
  • Adjuvant therapy must be completed at most 8 weeks prior to registration
  • No other prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy) or radiation therapy for the current colon cancer is permitted
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required
  • Age \>= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
  • Platelet count \>= 75 x 10\^9/L
  • Hemoglobin \> 9.0 g/dL
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
  • Corrected QT (QTc) Interval =\< 480 msec
  • Creatinine = calculated (calc.) creatinine clearance \>= 40 mL/min
  • No evidence of active and uncontrolled bacterial or viral infection (including active hepatitis B or hepatitis C infection) within 2 weeks prior to start of study intervention; exceptions include:
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • \* Participants who are hepatitis B surface antigen (HBsAg) negative (-), hepatitis B core antibody (HBcAb) positive (+) are eligible and should be monitored/treated as per local standard of care
  • No medical condition such as uncontrolled infection, uncontrolled diabetes mellitus, or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
  • Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents in the last 12 months, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • No uncontrolled or poorly-controlled hypertension (\> 180 mmHg systolic or \> 130 mmHg diastolic)
  • No history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab
  • No "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for \>= 3 years
    • Patients are not considered to have a "currently active" malignancy if they had a gastric or bowel carcinoid \< 1 cm, ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS) of the breast without invasive cancer, or endometrial dysplasia/carcinoma in situ
    • Patients are not considered to have a "currently active" malignancy if they had a sebaceous neoplasm (sebaceous adenoma, sebaceous epithelioma, sebaceous adenocarcinoma, keratoacanthoma, and squamous cell carcinoma) that was noninvasive
  • No known medical condition causing an inability to swallow oral formulations of agents
  • No residual Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade \>= 2 toxicity from prior chemotherapy, with the exception of grade 2 alopecia or neuropathy
  • Drugs that prolong the QTc interval should be avoided if possible, as encorafenib can prolong the QTc interval. Drugs that are generally accepted to have a risk of causing Torsades de Pointes should be discontinued or replaced with drugs that do not carry this risk if at all possible. Patients who receive potential QTc-prolonging medications should be monitored closely
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed during treatment on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed during treatment on this study. Patients must discontinue the drug 14 days prior to registration on the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (202)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
Hawaii Cancer Care - Westridge
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‘AieaUnited StatesUnknown status
Lehigh Valley Hospital-Cedar Crest
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AllentownUnited StatesUnknown status
Community Hospital of Anaconda
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AnacondaUnited StatesUnknown status
Mission Cancer and Blood - Ankeny
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AnkenyUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesUnknown status
Langlade Hospital and Cancer Center
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AntigoUnited StatesUnknown status
ThedaCare Regional Cancer Center
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AppletonUnited StatesUnknown status
Emory Saint Joseph's Hospital
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AtlantaUnited StatesUnknown status
Emory University Hospital Midtown
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AtlantaUnited StatesUnknown status
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Rush-Copley Medical Center
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AuroraUnited StatesUnknown status
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesUnknown status
Sanford Joe Lueken Cancer Center
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BemidjiUnited StatesUnknown status
ThedaCare Cancer Care - Berlin
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BerlinUnited StatesUnknown status
Lehigh Valley Hospital - Muhlenberg
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BethlehemUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Sanford Bismarck Medical Center
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BismarckUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Prisma Health Cancer Institute - Spartanburg
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Boiling SpringsUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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BrightonUnited StatesUnknown status
Trinity Health Medical Center - Brighton
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BrightonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesUnknown status
Illinois CancerCare-Canton
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CantonUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Canton
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CantonUnited StatesUnknown status
Trinity Health Medical Center - Canton
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CantonUnited StatesUnknown status
Aultman Health Foundation
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CantonUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Illinois CancerCare-Carthage
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CarthageUnited StatesUnknown status
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesUnknown status
Mercy Hospital
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Cedar RapidsUnited StatesUnknown status
Miami Valley Hospital South
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CentervilleUnited StatesUnknown status
West Virginia University Charleston Division
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CharlestonUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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ChelseaUnited StatesUnknown status
Chelsea Hospital
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ChelseaUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Cleveland Clinic Cancer Center/Fairview Hospital
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ClevelandUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Southeastern Medical Oncology Center-Clinton
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ClintonUnited StatesUnknown status
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesUnknown status
Memorial Sloan Kettering Commack
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CommackUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Northwest Cancer Center - Main Campus
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Crown PointUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesUnknown status
Parkland Memorial Hospital
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DallasUnited StatesUnknown status
UT Southwestern Simmons Cancer Center - RedBird
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DallasUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Premier Blood and Cancer Center
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DaytonUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesUnknown status
Mission Cancer and Blood - Des Moines
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Des MoinesUnited StatesUnknown status
Illinois CancerCare-Dixon
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DixonUnited StatesUnknown status
Northwest Oncology LLC
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DyerUnited StatesUnknown status
Prisma Health Cancer Institute - Easley
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EasleyUnited StatesUnknown status
Pocono Medical Center
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East StroudsburgUnited StatesUnknown status
Memorial Sloan Kettering Westchester
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East White PlainsUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
The Queen's Medical Center - West Oahu
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‘Ewa BeachUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Sanford Roger Maris Cancer Center
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FargoUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Genesee Hematology Oncology PC
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FlintUnited StatesUnknown status
Genesys Hurley Cancer Institute
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FlintUnited StatesUnknown status
Cancer Hematology Centers - Flint
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FlintUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Fort Worth
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Fort WorthUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesUnknown status
Gibbs Cancer Center-Gaffney
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GaffneyUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
CaroMont Regional Medical Center
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GastoniaUnited StatesUnknown status
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesUnknown status
Glens Falls Hospital
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Glens FallsUnited StatesUnknown status
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesUnknown status
Southeastern Medical Oncology Center-Goldsboro
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GoldsboroUnited StatesUnknown status
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Miami Valley Cancer Care and Infusion
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Faris
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Butternut
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Greer
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GreerUnited StatesUnknown status
Gibbs Cancer Center-Pelham
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GreerUnited StatesUnknown status
Geisinger Medical Center-Cancer Center Hazleton
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HazletonUnited StatesUnknown status
Saint Mary Medical Center
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HobartUnited StatesUnknown status
Northwest Cancer Center - Hobart
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HobartUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Queen's Cancer Cenrer - POB I
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
Cleveland Clinic Cancer Center Independence
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IndependenceUnited StatesUnknown status
Saint Catherine Hospital
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IndianapolisUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
Southeastern Medical Oncology Center-Jacksonville
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JacksonvilleUnited StatesUnknown status
Emory Johns Creek Hospital
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Johns CreekUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
Geisinger Medical Oncology-Lewisburg
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LewisburgUnited StatesUnknown status
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited StatesUnknown status
Henry Ford Saint John Hospital - Macomb Medical
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MacombUnited StatesUnknown status
Cleveland Clinic Cancer Center Mansfield
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MansfieldUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Hillcrest Hospital Cancer Center
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Mayfield HeightsUnited StatesUnknown status
Aspirus Medford Hospital
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MedfordUnited StatesUnknown status
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesUnknown status
Beebe South Coastal Health Campus
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MillvilleUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesUnknown status
Community Medical Center
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MissoulaUnited StatesUnknown status
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesUnknown status
ProHealth D N Greenwald Center
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MukwonagoUnited StatesUnknown status
The Community Hospital
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MunsterUnited StatesUnknown status
Women's Diagnostic Center - Munster
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MunsterUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesUnknown status
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesUnknown status
ThedaCare Regional Medical Center - Neenah
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NeenahUnited StatesUnknown status
Helen F Graham Cancer Center
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NewarkUnited StatesUnknown status
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesUnknown status
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Ontario
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OntarioUnited StatesUnknown status
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesUnknown status
Northwestern Medicine Orland Park
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Orland ParkUnited StatesUnknown status
Upstate Cancer Center at Oswego
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OswegoUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesUnknown status
Geisinger Cancer Services-Pottsville
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PottsvilleUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Beebe Health Campus
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Rehoboth BeachUnited StatesUnknown status
Aspirus Cancer Care - James Beck Cancer Center
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RhinelanderUnited StatesUnknown status
UT Southwestern Clinical Center at Richardson/Plano
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RichardsonUnited StatesUnknown status
MyMichigan Medical Center Saginaw
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SaginawUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesUnknown status
North Coast Cancer Care
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SanduskyUnited StatesUnknown status
Community Medical Center
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ScrantonUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Prisma Health Cancer Institute - Seneca
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SenecaUnited StatesUnknown status
ThedaCare Cancer Care - Shawano
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ShawanoUnited StatesUnknown status
Sanford Cancer Center Oncology Clinic
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Sioux FallsUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Aspirus Cancer Care - Stevens Point
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Stevens PointUnited StatesUnknown status
Cleveland Clinic Cancer Center Strongsville
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StrongsvilleUnited StatesUnknown status
SUNY Upstate Medical Center-Community Campus
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SyracuseUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Toledo Clinic Cancer Centers-Toledo
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ToledoUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesUnknown status
MGC Hematology Oncology-Union
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UnionUnited StatesUnknown status
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Northwest Cancer Center - Valparaiso
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ValparaisoUnited StatesUnknown status
Upstate Cancer Center at Verona
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VeronaUnited StatesUnknown status
South Pointe Hospital
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Warrensville HeightsUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesUnknown status
Illinois CancerCare - Washington
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WashingtonUnited StatesUnknown status
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesUnknown status
ThedaCare Cancer Care - Waupaca
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WaupacaUnited StatesUnknown status
Aspirus Regional Cancer Center
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WausauUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesUnknown status
Aspirus Cancer Care - Wisconsin Rapids
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Wisconsin RapidsUnited StatesUnknown status
Cleveland Clinic Wooster Family Health and Surgery Center
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WoosterUnited StatesUnknown status
Rush-Copley Healthcare Center
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YorkvilleUnited StatesUnknown status
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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YpsilantiUnited StatesUnknown status
Huron Gastroenterology PC
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.