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NCT01959139CompletedPhase 1/2

S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma

Source: ClinicalTrials.gov · Last updated 9 Feb 2024

Brief summary (registry, in English)

This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
126 (actual)
First submitted
30 Sept 2013
Start date
23 Jan 2014
Primary completion date
Apr 2019
Lead sponsor
SWOG Cancer Research Network
NCT number
NCT01959139

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 126
  • From 23 Jan 2014 to the primary completion date, Apr 2019
  • 154 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.

Criteria the registry did not label

  • Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases
  • Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
  • Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3 years prior to registration; patients must not have had prior chemotherapy in metastatic setting; prior abdominal radiation therapy is not allowed
  • Patients must have a Zubrod performance status of 0-1
  • Absolute neutrophil count (ANC) \>= 1,500/mcL
  • Platelets \>= 100,000/mcL
  • Hemoglobin \>= 9 g/dL
  • Total bilirubin =\< institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =\< 2.5 X IULN in the absence of liver metastases or =\< 5.0 x IULN with liver metastasis
  • Serum albumin \>= 3 g/dL
  • Serum creatinine =\< ULN within 14 days prior to registration OR calculated creatinine clearance \> 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
  • Patients must have international normalized ratio (INR) =\< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration)
  • Patients must not be receiving chronic treatment (equivalent of prednisone \> 10 mg/day) with systemic steroids or other immuno-suppressive agent
  • Patients must not have liver disease such a cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
  • Patients with a known history of human immunodeficiency virus (HIV) must not be on active treatment for HIV
  • Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy
  • 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 five years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; 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; 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
  • Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples
  • Patients or their legally authorized representative 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
  • 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
  • Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (154)

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

SiteCityCountrySite status
Providence Regional Cancer System-Aberdeen
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AberdeenUnited StatesUnknown status
Cancer Care Center at Island Hospital
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AnacortesUnited StatesUnknown status
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesUnknown status
Alaska Women's Cancer Care
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AnchorageUnited StatesUnknown status
Katmai Oncology Group
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AnchorageUnited StatesUnknown status
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesUnknown status
Providence Alaska Medical Center
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AnchorageUnited StatesUnknown status
Randolph Hospital
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AsheboroUnited StatesUnknown status
Sutter Auburn Faith Hospital
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AuburnUnited StatesUnknown status
Sutter Cancer Centers Radiation Oncology Services-Auburn
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AuburnUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
Saint Charles Health System
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BendUnited StatesUnknown status
Alta Bates Summit Medical Center-Herrick Campus
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BerkeleyUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Saint Joseph Medical Center
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BloomingtonUnited StatesUnknown status
Saint Luke's Mountain States Tumor Institute
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BoiseUnited StatesUnknown status
Parkland Health Center-Bonne Terre
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Bonne TerreUnited StatesUnknown status
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesUnknown status
Mills - Peninsula Hospitals
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BurlingameUnited StatesUnknown status
Cone Health Cancer Center at Alamance Regional
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BurlingtonUnited StatesUnknown status
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Cameron ParkUnited StatesUnknown status
Illinois CancerCare-Canton
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CantonUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Southeast Cancer Center
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Cape GirardeauUnited StatesUnknown status
Memorial Hospital of Carbondale
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CarbondaleUnited StatesUnknown status
Illinois CancerCare-Carthage
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CarthageUnited StatesUnknown status
Eden Hospital Medical Center
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Castro ValleyUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Providence Oncology and Hematology Care Southeast
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ClackamasUnited StatesUnknown status
Clackamas Radiation Oncology Center
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ClackamasUnited StatesUnknown status
Southeastern Medical Oncology Center-Clinton
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ClintonUnited StatesUnknown status
Bay Area Hospital
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Coos BayUnited StatesUnknown status
City of Hope Corona
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CoronaUnited StatesUnknown status
UC Irvine Health Cancer Center-Newport
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Costa MesaUnited StatesUnknown status
Sutter Davis Hospital
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DavisUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Center of Decatur
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DecaturUnited StatesUnknown status
Smilow Cancer Hospital-Derby Care Center
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DerbyUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Swedish Medical Center-Edmonds
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EdmondsUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
Providence Regional Cancer Partnership
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EverettUnited StatesUnknown status
Smilow Cancer Hospital Care Center-Fairfield
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FairfieldUnited StatesUnknown status
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesUnknown status
Saint Luke's Mountain States Tumor Institute - Fruitland
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FruitlandUnited StatesUnknown status
Western Illinois Cancer Treatment Center
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GalesburgUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
Wayne Memorial Hospital
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GoldsboroUnited StatesUnknown status
Southeastern Medical Oncology Center-Goldsboro
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GoldsboroUnited StatesUnknown status
Cone Health Cancer Center
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GreensboroUnited StatesUnknown status
Medical Oncology and Hematology Group PC-Guilford
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GuilfordUnited StatesUnknown status
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesUnknown status
Margaret R Pardee Memorial Hospital
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HendersonvilleUnited StatesUnknown status
Hendersonville Hematology and Oncology at Pardee
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HendersonvilleUnited StatesUnknown status
Centerpoint Medical Center LLC
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IndependenceUnited 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
Capital Region Medical Center-Goldschmidt Cancer Center
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Jefferson CityUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Research Medical Center
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Kansas CityUnited StatesUnknown status
Heartland Hematology and Oncology Associates Incorporated
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Kansas CityUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
Seattle Cancer Care Alliance at EvergreenHealth
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KirklandUnited StatesUnknown status
Providence Regional Cancer System-Lacey
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LaceyUnited StatesUnknown status
Saint Luke's East - Lee's Summit
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Lee's SummitUnited StatesUnknown status
Minimally Invasive Surgery Hospital
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LenexaUnited StatesUnknown status
Kansas Institute of Medicine Cancer and Blood Center
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LenexaUnited StatesUnknown status
Liberty Radiation Oncology Center
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LibertyUnited StatesUnknown status
PeaceHealth Saint John Medical Center
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LongviewUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Los Angeles County-USC Medical Center
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Los AngelesUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited StatesUnknown status
Fremont - Rideout Cancer Center
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MarysvilleUnited StatesUnknown status
Cone Heath Cancer Center at Mebane
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MebaneUnited StatesUnknown status
Saint Luke's Mountain States Tumor Institute - Meridian
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MeridianUnited StatesUnknown status
Memorial Medical Center
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ModestoUnited StatesUnknown status
Palo Alto Medical Foundation-Gynecologic Oncology
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Mountain ViewUnited StatesUnknown status
Palo Alto Medical Foundation-Camino Division
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Mountain ViewUnited StatesUnknown status
Saint Luke's Mountain States Tumor Institute - Nampa
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NampaUnited StatesUnknown status
Providence Newberg Medical Center
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NewbergUnited StatesUnknown status
Smilow Cancer Center/Yale-New Haven Hospital
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New HavenUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Yale-New Haven Hospital North Haven Medical Center
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North HavenUnited StatesUnknown status
Sutter Cancer Research Consortium
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NovatoUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Smilow Cancer Hospital-Orange Care Center
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OrangeUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesUnknown status
Radiation Oncology of Northern Illinois
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OttawaUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Menorah Medical Center
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Overland ParkUnited StatesUnknown status
Saint Luke's South Hospital
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Overland ParkUnited StatesUnknown status
Palo Alto Medical Foundation Health Care
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Palo AltoUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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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
OSF Saint Francis Medical Center
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PeoriaUnited StatesUnknown status
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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PeoriaUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
Valley Radiation Oncology
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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
Kansas City NCI Community Oncology Research Program
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Prairie VillageUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Annie Penn Memorial Hospital
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ReidsvilleUnited StatesUnknown status
Sutter Cancer Centers Radiation Oncology Services-Roseville
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RosevilleUnited StatesUnknown status
Sutter Roseville Medical Center
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RosevilleUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Sutter General Hospital
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SacramentoUnited StatesUnknown status
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesUnknown status
Heartland Regional Medical Center
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Saint JosephUnited StatesUnknown status
California Pacific Medical Center-Pacific Campus
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San FranciscoUnited StatesUnknown status
Palo Alto Medical Foundation-Santa Cruz
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Santa CruzUnited StatesUnknown status
Sutter Pacific Medical Foundation
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Santa RosaUnited StatesUnknown status
Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
Pacific Gynecology Specialists
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SeattleUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Group Health Cooperative-Seattle
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SeattleUnited StatesUnknown status
Minor and James Medical PLLC
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SeattleUnited StatesUnknown status
Providence Regional Cancer System-Shelton
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SheltonUnited StatesUnknown status
Rockwood Cancer Treatment Center-DHEC-Downtown
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SpokaneUnited StatesUnknown status
Rockwood Clinic Cancer Treatment Center-Valley
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Spokane ValleyUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Central Illinois Hematology Oncology Center
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SpringfieldUnited StatesUnknown status
Memorial Medical Center
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SpringfieldUnited 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
Palo Alto Medical Foundation-Sunnyvale
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SunnyvaleUnited StatesUnknown status
Missouri Baptist Outpatient Center-Sunset Hills
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Sunset HillsUnited StatesUnknown status
Cancer Care Specialists of Illinois-Swansea
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SwanseaUnited StatesUnknown status
Charlotte Hungerford Hospital Center for Cancer Care
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TorringtonUnited StatesUnknown status
Gene Upshaw Memorial Tahoe Forest Cancer Center
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TruckeeUnited StatesUnknown status
Smilow Cancer Hospital Care Center-Trumbull
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TrumbullUnited StatesUnknown status
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesUnknown status
The University of Arizona Medical Center-University Campus
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TucsonUnited StatesUnknown status
Saint Luke's Mountain States Tumor Institute-Twin Falls
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Twin FallsUnited StatesUnknown status
Sutter Cancer Centers Radiation Oncology Services-Vacaville
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VacavilleUnited StatesUnknown status
Sutter Solano Medical Center/Cancer Center
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VallejoUnited StatesUnknown status
PeaceHealth Southwest Medical Center
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VancouverUnited StatesUnknown status
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesUnknown status
Smilow Cancer Hospital-Waterbury Care Center
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WaterburyUnited StatesUnknown status
City of Hope West Covina
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West CovinaUnited StatesUnknown status
Southeastern Medical Oncology Center-Wilson
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WilsonUnited StatesUnknown status
Providence Regional Cancer System-Yelm
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YelmUnited StatesUnknown status

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