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NCT04310020Active, not recruitingPhase 2

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

This phase II trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more cancer cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to test the safety and effectiveness of radiation therapy followed by atezolizumab and find out what side effects, if any, it has on patient's non-small cell lung cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
47 (estimated)
First submitted
16 Mar 2020
Start date
13 Jan 2021
Primary completion date
1 Jun 2027
Lead sponsor
National Cancer Institute (NCI)
Diseases
Lung cancer
NCT number
NCT04310020

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 47
  • From 13 Jan 2021 to the primary completion date, 1 Jun 2027
  • 170 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

  • REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)
  • REGISTRATION STEP 1: Participants must have stage III NSCLC with Zubrod performance status of 2 or stage II NSCLC with Zubrod performance status of 0-2
  • REGISTRATION STEP 1: Participants must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection
  • REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator
  • REGISTRATION STEP 1: Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
  • REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1
  • REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist
  • REGISTRATION STEP 1: Participants may have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment
  • REGISTRATION STEP 1: Participants may have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study
  • REGISTRATION STEP 1: Participants must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery
  • REGISTRATION STEP 1: Absolute neutrophil count (ANC) \>= 1500/mcl (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Platelet count \>= 100,000/mcl (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Hemoglobin \>= 9 grams/dL (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x IULN (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Serum creatinine =\< 1.5 x IULN OR measured or calculated creatinine clearance \>= 40 mL/min (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Participants must have percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 40% documented within 90 days prior to Registration Step 1
  • REGISTRATION STEP 1: Patient must not have had a prior history of interstitial lung disease or \> grade 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5) pneumonitis
  • REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months
  • REGISTRATION STEP 1: Participants must not have an active infection requiring therapy
  • REGISTRATION STEP 1: Participants must be ≥ 18 years old
  • REGISTRATION STEP 1: Participants must not be pregnant or nursing because atezolizumab has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on protocol treatment and for five months after last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • REGISTRATION STEP 1: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1
  • REGISTRATION STEP 1: Patient must be tested for hepatitis B within 28 days prior to Registration Step 1. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
  • REGISTRATION STEP 1: Patients must not have active hepatitis C virus (HCV) infection. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test. Patient must have an HCV antibody test within 28 days prior to Registration Step 1. If the HCV antibody test is positive, the patient must also have an HCV quantitative RNA test within 28 days prior to Registration Step 1
  • REGISTRATION STEP 1: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible
  • REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research
  • REGISTRATION STEP 1: Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • REGISTRATION STEP 1: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • REGISTRATION STEP 2: Participants must be registered to Step 2 within 42 days after completion of radiation treatment. Participants must have received at least 44 Gy of radiation treatment
  • REGISTRATION STEP 2: Participants must have no evidence of progression per RECIST 1.1 on CT scan of the chest, abdomen, and pelvis performed between 2 and 5 weeks after completion of radiation therapy
  • REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to \< grade 2
  • REGISTRATION STEP 2: ANC \>= 1.5 x 10\^3/uL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Platelet count \>= 100 x 10\^3/uL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Hemoglobin \>= 9 grams/dL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: AST and ALT =\< 2.5 x IULN (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Serum creatinine =\< 1.5 x IULN OR measured or calculated creatinine clearance \>= 40 mL/min (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Participants must not have received steroids in doses of more than prednisone 10 mg daily or equivalent within 14 days prior to Registration Step 2
  • REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2

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

Full criteria on ClinicalTrials.gov

Sites (170)

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

SiteCityCountrySite status
Queen's Cancer Center - Pearlridge
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‘AieaUnited StatesUnknown status
Hawaii Cancer Care - Westridge
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‘AieaUnited StatesUnknown status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
The Cancer Center of Hawaii-Pali Momi
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‘AieaUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
McFarland Clinic - Ames
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AmesUnited StatesUnknown status
Mary Greeley Medical Center
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AmesUnited StatesUnknown status
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesUnknown status
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesUnknown status
Katmai Oncology Group
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AnchorageUnited StatesUnknown status
Alaska Women's Cancer Care
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AnchorageUnited StatesUnknown status
Providence Alaska Medical Center
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AnchorageUnited StatesUnknown status
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesUnknown status
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
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AppletonUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
Mount Sinai Comprehensive Cancer Center at Aventura
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AventuraUnited StatesUnknown status
Beverly Hospital
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BeverlyUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
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BrookfieldUnited StatesUnknown status
Lahey Clinic
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BurlingtonUnited StatesUnknown status
Illinois CancerCare-Canton
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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
Dayton Physicians LLC-Miami Valley South
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CentervilleUnited StatesUnknown status
Miami Valley Hospital South
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CentervilleUnited StatesUnknown status
Saint Mary's Hospital
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CentraliaUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
Jesse Brown Veterans Affairs Medical Center
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ChicagoUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Ascension Calumet Hospital-Chilton
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ChiltonUnited StatesUnknown status
Clackamas Radiation Oncology Center
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ClackamasUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesUnknown status
Mercy Cancer Center-West Lakes
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CliveUnited StatesUnknown status
Baptist Memorial Hospital and Cancer Center-Collierville
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ColliervilleUnited StatesUnknown status
Greater Regional Medical Center
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CrestonUnited StatesUnknown status
UT Southwestern Simmons Cancer Center - RedBird
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DallasUnited 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
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Dayton Physician LLC - Englewood
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DaytonUnited StatesUnknown status
Premier Blood and Cancer Center
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
AdventHealth Porter
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DenverUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesUnknown status
Iowa Methodist Medical Center
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Des MoinesUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesUnknown status
Iowa Lutheran Hospital
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Des MoinesUnited StatesUnknown status
Broadlawns Medical Center
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Des MoinesUnited StatesUnknown status
Mercy Medical Center - Des Moines
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Des MoinesUnited 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
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
UPMC Hillman Cancer Center Erie
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ErieUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
Parkland Health Center - Farmington
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FarmingtonUnited StatesUnknown status
UPMC Cancer Center at UPMC Horizon
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FarrellUnited 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
Ascension Southeast Wisconsin Hospital - Franklin
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FranklinUnited StatesUnknown status
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
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FranklinUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
Addison Gilbert Hospital
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GloucesterUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
UPMC Cancer Centers - Arnold Palmer Pavilion
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GreensburgUnited StatesUnknown status
Miami Valley Cancer Care and Infusion
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GreenvilleUnited StatesUnknown status
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
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GreenvilleUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Queen's Cancer Cenrer - POB I
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc-Liliha
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HonoluluUnited StatesUnknown status
Island Urology
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HonoluluUnited StatesUnknown status
The Cancer Center of Hawaii-Liliha
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HonoluluUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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JonesboroUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
Cancer Centers of Southwest Oklahoma Research
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LawtonUnited StatesUnknown status
CommonSpirit Saint Joseph Hospital - Lexington
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LexingtonUnited StatesUnknown status
CommonSpirit Saint Joseph Medical Center - East Lexington
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LexingtonUnited StatesUnknown status
Saint Joseph Radiation Oncology Resource Center
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LexingtonUnited StatesUnknown status
Wilcox Memorial Hospital and Kauai Medical Clinic
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LihueUnited StatesUnknown status
AdventHealth Littleton
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LittletonUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited 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
Baptist Memorial Hospital and Cancer Center-Memphis
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MemphisUnited StatesUnknown status
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
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MequonUnited StatesUnknown status
Mount Sinai Medical Center
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Miami BeachUnited StatesUnknown status
Ascension Saint Francis Hospital-Milwaukee
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MilwaukeeUnited StatesUnknown status
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
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MilwaukeeUnited StatesUnknown status
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
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MilwaukeeUnited StatesUnknown status
Health Partners Inc
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MinneapolisUnited StatesUnknown status
Hennepin County Medical Center
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MinneapolisUnited StatesUnknown status
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesUnknown status
UPMC Cancer Center - Monroeville
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MonroevilleUnited StatesUnknown status
UPMC Hillman Cancer Center - Monroeville
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MonroevilleUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesUnknown status
UPMC Hillman Cancer Center - New Castle
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New CastleUnited StatesUnknown status
CTCA at Southeastern Regional Medical Center
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NewnanUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
Henry Ford Health Providence Novi Hospital
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NoviUnited StatesUnknown status
HSHS Saint Elizabeth's Hospital
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O'FallonUnited 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
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
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OshkoshUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
AdventHealth Parker
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ParkerUnited StatesUnknown status
Lahey Clinic Peabody
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PeabodyUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
Methodist Medical Center of Illinois
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
UPMC-Passavant Hospital
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PittsburghUnited StatesUnknown status
UPMC Hillman Cancer Center
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PittsburghUnited StatesUnknown status
UPMC-Shadyside Hospital
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PittsburghUnited StatesUnknown status
UPMC-Saint Clair Hospital Cancer Center
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PittsburghUnited StatesUnknown status
UPMC-Saint Margaret
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PittsburghUnited 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
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Ascension All Saints Hospital-Spring Street-Racine
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RacineUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
UT Southwestern Clinical Center at Richardson/Plano
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RichardsonUnited StatesUnknown status
Phelps Health Delbert Day Cancer Institute
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RollaUnited StatesUnknown status
Mercy Clinic-Rolla-Cancer and Hematology
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RollaUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesUnknown status
Swedish Medical Center-Cherry Hill
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
UPMC Cancer Center at UPMC Northwest
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SenecaUnited StatesUnknown status
Henry Ford Health Providence Southfield Hospital
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SouthfieldUnited StatesUnknown status
Baptist Memorial Hospital and Cancer Center-Desoto
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SouthhavenUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Mercy Hospital Springfield
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Lakeview Hospital
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StillwaterUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Weiler Hospital
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The BronxUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
Dayton Physicians LLC - Troy
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TroyUnited StatesUnknown status
The Carle Foundation Hospital
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UrbanaUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Illinois CancerCare - Washington
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WashingtonUnited StatesUnknown status
UPMC Washington Hospital Radiation Oncology
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WashingtonUnited StatesUnknown status
UPMC Cancer Center-Washington
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WashingtonUnited StatesUnknown status
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesUnknown status
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
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WauwatosaUnited StatesUnknown status
Mercy Medical Center-West Lakes
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West Des MoinesUnited StatesUnknown status
Methodist West Hospital
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West Des MoinesUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
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WinchesterUnited StatesUnknown status

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