Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

NCT ID: NCT00887146

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2029-10-31

Brief Summary

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Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Detailed Description

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This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. \> 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma).

The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --\> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --\> PCV)(Arm A).

Secondary Goals:

1. Time to Progression - To determine whether patients who receive (RT + TMZ --\> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT --\> PCV).
2. Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status.
3. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.
4. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons.
5. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints.
6. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations.

After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (RT, procarbazine, lomustine, vincristine)

Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

procarbazine

Intervention Type DRUG

Days 8-21: 60 mg/m\^2 orally

CCNU

Intervention Type DRUG

Day 1: 110 mg/m\^2 orally

vincristine

Intervention Type DRUG

Days 8 and 29: 1.4 mg/m\^2 IV

Arm B (RT, temozolomide)

Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.

Group Type EXPERIMENTAL

concomitant temozolomide (TMZ)

Intervention Type DRUG

75 mg/m\^2, orally daily

radiotherapy

Intervention Type RADIATION

adjuvant temozolomide (TMZ)

Intervention Type DRUG

150 or 200 mg/m\^2 orally

Interventions

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concomitant temozolomide (TMZ)

75 mg/m\^2, orally daily

Intervention Type DRUG

radiotherapy

Intervention Type RADIATION

procarbazine

Days 8-21: 60 mg/m\^2 orally

Intervention Type DRUG

adjuvant temozolomide (TMZ)

150 or 200 mg/m\^2 orally

Intervention Type DRUG

CCNU

Day 1: 110 mg/m\^2 orally

Intervention Type DRUG

vincristine

Days 8 and 29: 1.4 mg/m\^2 IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* United States (US) and Canadian sites:

\* This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
* Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review

* Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act \[CLIA\] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS)
* Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS


* Newly diagnosed and =\< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure \> 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy
* Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study

\* Note: mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q
* Patients with codeleted low grade gliomas must also be considered "high risk" by exhibiting one or more of the following characteristics:

* Age \>= 40 and any surgical therapy
* Age \< 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)
* Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy)
* Intractable seizures
* Surgery (partial or gross total resection or biopsy) must be performed \>= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3 obtained =\< 21 days prior to registration
* Platelet (PLTs) count \>= 100,000/mm\^3 obtained =\< 21 days prior to registration
* Hemoglobin (Hgb) \> 9.0 g/dL obtained =\< 21 days prior to registration
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) obtained =\< 21 days prior to registration
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x ULN obtained =\< 21 days prior to registration
* Creatinine =\< 1.5 x ULN obtained =\< 21 days prior to registration
* Negative serum or urine pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
* Written informed consent
* Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose
* Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient

Exclusion Criteria

* The following categories are ineligible:

* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments
* History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma are eligible for the study
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
* Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy are not eligible; note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm
* Other active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, the patient is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brain
* History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

European Organisation for Research and Treatment Center (EORTC)

UNKNOWN

Sponsor Role collaborator

Canadian Cancer Trials Group

NETWORK

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Jaeckle, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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Riverside Methodist Hospital

Columbus, Ohio, United States

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The Mark H Zangmeister Center

Columbus, Ohio, United States

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Mount Carmel Health Center West

Columbus, Ohio, United States

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Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

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ProMedica Flower Hospital

Sylvania, Ohio, United States

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Saint Ann's Hospital

Westerville, Ohio, United States

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Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

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Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

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Legacy Mount Hood Medical Center

Gresham, Oregon, United States

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Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

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Providence Portland Medical Center

Portland, Oregon, United States

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Providence Saint Vincent Medical Center

Portland, Oregon, United States

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Jefferson Abington Hospital

Abington, Pennsylvania, United States

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Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

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Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

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Geisinger Medical Center

Danville, Pennsylvania, United States

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Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, United States

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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Temple University Hospital

Philadelphia, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

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Reading Hospital

West Reading, Pennsylvania, United States

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Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

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Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

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Medical University of South Carolina

Charleston, South Carolina, United States

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Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

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Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

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Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

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Spartanburg Medical Center

Spartanburg, South Carolina, United States

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

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Providence Hospital

Mobile, Alabama, United States

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

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Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

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Alaska Women's Cancer Care

Anchorage, Alaska, United States

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Anchorage Oncology Centre

Anchorage, Alaska, United States

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Katmai Oncology Group

Anchorage, Alaska, United States

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Providence Alaska Medical Center

Anchorage, Alaska, United States

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Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

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Arizona Oncology-Deer Valley Center

Phoenix, Arizona, United States

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Arizona Oncology Services Foundation

Scottsdale, Arizona, United States

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Kaiser Permanente-Anaheim

Anaheim, California, United States

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Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

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Mills-Peninsula Medical Center

Burlingame, California, United States

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Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

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Community Cancer Institute

Clovis, California, United States

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University Oncology Associates

Clovis, California, United States

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UC San Diego Moores Cancer Center

La Jolla, California, United States

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Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

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Cedars Sinai Medical Center

Los Angeles, California, United States

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Memorial Medical Center

Modesto, California, United States

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Kaiser Permanente Oakland-Broadway

Oakland, California, United States

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Kaiser Permanente-Ontario

Ontario, California, United States

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Rapid City Regional Hospital

Rapid City, South Dakota, United States

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UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

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Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

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Sutter Roseville Medical Center

Roseville, California, United States

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Sutter Medical Center Sacramento

Sacramento, California, United States

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University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

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Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

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Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

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The Medical Center of Aurora

Aurora, Colorado, United States

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UCHealth University of Colorado Hospital

Aurora, Colorado, United States

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Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

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Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

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UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

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Saint Francis Cancer Center

Colorado Springs, Colorado, United States

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Porter Adventist Hospital

Denver, Colorado, United States

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Saint Anthony Hospital

Lakewood, Colorado, United States

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Littleton Adventist Hospital

Littleton, Colorado, United States

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Longmont United Hospital

Longmont, Colorado, United States

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Banner McKee Medical Center

Loveland, Colorado, United States

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Parker Adventist Hospital

Parker, Colorado, United States

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Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

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Yale University

New Haven, Connecticut, United States

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Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

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Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

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Boca Raton Regional Hospital

Boca Raton, Florida, United States

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University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

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Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

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Mayo Clinic in Florida

Jacksonville, Florida, United States

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AdventHealth Orlando

Orlando, Florida, United States

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Orlando Health Cancer Institute

Orlando, Florida, United States

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Emory Proton Therapy Center

Atlanta, Georgia, United States

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Emory University Hospital Midtown

Atlanta, Georgia, United States

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Piedmont Hospital

Atlanta, Georgia, United States

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

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Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

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Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

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Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

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Illinois CancerCare-Canton

Canton, Illinois, United States

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Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

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Northwestern University

Chicago, Illinois, United States

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University of Illinois

Chicago, Illinois, United States

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University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

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Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

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Decatur Memorial Hospital

Decatur, Illinois, United States

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Crossroads Cancer Center

Effingham, Illinois, United States

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Illinois CancerCare-Eureka

Eureka, Illinois, United States

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Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

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Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

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Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

AMITA Health Adventist Medical Center

La Grange, Illinois, United States

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Illinois CancerCare-Macomb

Macomb, Illinois, United States

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Loyola University Medical Center

Maywood, Illinois, United States

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Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

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Memorial Medical Center

Springfield, Illinois, United States

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Parkview Hospital Randallia

Fort Wayne, Indiana, United States

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Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Site Status

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

Mission Cancer and Blood - West Des Moines

Clive, Iowa, United States

Site Status

Greater Regional Medical Center

Creston, Iowa, United States

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Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Mission Cancer and Blood - Des Moines

Des Moines, Iowa, United States

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Broadlawns Medical Center

Des Moines, Iowa, United States

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Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

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Mission Cancer and Blood - Laurel

Des Moines, Iowa, United States

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Iowa Lutheran Hospital

Des Moines, Iowa, United States

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Methodist West Hospital

West Des Moines, Iowa, United States

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Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

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University of Kansas Cancer Center

Kansas City, Kansas, United States

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University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

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University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

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University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

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University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

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Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States

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Norton Brownsboro Hospital and Medical Campus

Louisville, Kentucky, United States

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West Jefferson Medical Center

Marrero, Louisiana, United States

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Maine Medical Center-Bramhall Campus

Portland, Maine, United States

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Maine Medical Center- Scarborough Campus

Scarborough, Maine, United States

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Maine Medical Partners Neurology

Scarborough, Maine, United States

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Maine Medical Partners - South Portland

South Portland, Maine, United States

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Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

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Cancer Trials Support Unit

Rockville, Maryland, United States

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

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Bixby Medical Center

Adrian, Michigan, United States

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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Henry Ford Hospital

Detroit, Michigan, United States

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Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

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Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

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Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

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Munson Medical Center

Traverse City, Michigan, United States

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Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

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University of Michigan Health - West

Wyoming, Michigan, United States

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Fairview Ridges Hospital

Burnsville, Minnesota, United States

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Mercy Hospital

Coon Rapids, Minnesota, United States

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Essentia Health Cancer Center

Duluth, Minnesota, United States

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Miller-Dwan Hospital

Duluth, Minnesota, United States

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Fairview Southdale Hospital

Edina, Minnesota, United States

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Unity Hospital

Fridley, Minnesota, United States

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Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

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Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

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Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

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Regions Hospital

Saint Paul, Minnesota, United States

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United Hospital

Saint Paul, Minnesota, United States

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Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

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Lakeview Hospital

Stillwater, Minnesota, United States

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Ridgeview Medical Center

Waconia, Minnesota, United States

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Rice Memorial Hospital

Willmar, Minnesota, United States

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Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

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MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

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University of Kansas Cancer Center - North

Kansas City, Missouri, United States

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University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

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University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

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Saint Vincent Healthcare

Billings, Montana, United States

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Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status

Nebraska Hematology and Oncology

Lincoln, Nebraska, United States

Site Status

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Site Status

Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

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Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

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Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Nebraska Cancer Specialists - Omaha

Omaha, Nebraska, United States

Site Status

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Midlands Community Hospital

Papillion, Nebraska, United States

Site Status

Regional West Medical Center Cancer Center

Scottsbluff, Nebraska, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

GenesisCare USA - Las Vegas

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Saint George Regional Medical Center

St. George, Utah, United States

Site Status

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

VCU Community Memorial Health Center

South Hill, Virginia, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status

Tri-Cities Cancer Center

Kennewick, Washington, United States

Site Status

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington, United States

Site Status

Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

FHCC South Lake Union

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Medical University Vienna

Vienna, , Austria

Site Status

Alegemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

London Regional Cancer Program

London, Ontario, Canada

Site Status

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

Site Status

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Academ Zienkenhuis Bij De University

Amsterdam, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Maastro Clinic-Maastricht Radiation Oncology

Maastricht, , Netherlands

Site Status

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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United States Austria Belgium Canada France Netherlands

References

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Cerhan JH, Anderson SK, Butts AM, Porter AB, Jaeckle K, Galanis E, Brown PD. Examiner accuracy in cognitive testing in multisite brain-tumor clinical trials: an analysis from the Alliance for Clinical Trials in Oncology. Neurooncol Pract. 2019 Jul;6(4):283-288. doi: 10.1093/nop/npy048. Epub 2018 Nov 24.

Reference Type DERIVED
PMID: 31386061 (View on PubMed)

Drappatz J, Lieberman F. Chemotherapy of Oligodendrogliomas. Prog Neurol Surg. 2018;31:152-161. doi: 10.1159/000467376. Epub 2018 Jan 25.

Reference Type DERIVED
PMID: 29393183 (View on PubMed)

Related Links

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https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2011-01915&q=N0577

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

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NCI-2011-01915

Identifier Type: REGISTRY

Identifier Source: secondary_id

EORTC-26081-22086

Identifier Type: -

Identifier Source: secondary_id

EudraCT-2008-007295-14

Identifier Type: -

Identifier Source: secondary_id

CDR0000640442

Identifier Type: REGISTRY

Identifier Source: secondary_id

N0577

Identifier Type: -

Identifier Source: org_study_id

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