Trial record 1 of 1 for:    N0577
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Radiation Therapy With Concomitant and Adjuvant Temozolomide or Radiation Therapy With Adjuvant PCV or Temozolomide Alone in Treating Patients With Anaplastic Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00887146
First received: April 22, 2009
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 temozolomide alone, radiation followed by PCV, or temozolomide together with radiation therapy followed by temozolomide is more effective in treating anaplastic glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: Temozolomide (TMZ)
Radiation: Radiotherapy
Drug: PCV - Procarbazine + CCNU + Vincristine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Intergroup Study of Temozolomide Alone Versus Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 2 years post-registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years post-registration ] [ Designated as safety issue: No ]
  • Time to progression (i.e., clinical progression, neurocognitive progression, and radiographic progression) [ Time Frame: Up to 2 years post-registration ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: Up to 5 years post-registration ] [ Designated as safety issue: No ]
  • Treatment-related adverse events according to NCI CTCAE v. 3 [ Time Frame: Up to 5 years post-registration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: October 2009
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A - Radiotherapy followed by PCV
Patients undergo radiotherapy (RT) 5 days per week for approximately 6 - 7 weeks in Cycle 1. The patient undergoes a rest period for approximately 4 weeks in Cycle 2. For Cycles 3-8, patients are administered PCV chemotherapy for about 6 - 7 weeks for each cycle in the absence of disease progression and unacceptable toxicity.
Radiation: Radiotherapy
Patients undergo radiotherapy performed as 33 fractions of 1.8 Gy for a total dose of 59.4 Gy.
Drug: PCV - Procarbazine + CCNU + Vincristine
Patients receive PCV chemotherapy. On Day 1, CCNU 110 mg/m2 is administered orally. On Days 8 and 29, vincristine 1.4 mg/m2 is administered intravenously. And on Days 8-21, procarbazine 60 mg/m2 is administered orally. The course of treatment is repeated for a total of 6 cycles.
Experimental: Arm B - Radiotherapy + TMZ followed by TMZ
Patients undergo radiation and temozolomide treatment daily for Cycle 1 for approximately 6-7 weeks. Patients receive temozolomide 75 mg/m2 orally. There is a rest period for approximately 4 weeks during Cycle 2. For Cycles 3-8, patients undergo adjuvant temozolomide 150 or 1200 mg/m2 orally on Days 1-5 of each cycle. Each cycle is approximately 4 weeks in duration. Temozolomide may be extended to 12 cycles if there is acceptable tolerance and no evidence of progression.
Drug: Temozolomide (TMZ)
Patients receive oral temozolomide.
Radiation: Radiotherapy
Patients undergo radiotherapy performed as 33 fractions of 1.8 Gy for a total dose of 59.4 Gy.
Experimental: Arm C - TMZ
Patients receive oral temozolomide 150 or 1200 mg/m2 once daily on days 1-5 of each cycle. Each cycle is approximately 4 weeks. Patients undergo treatment for a total of 12 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Temozolomide (TMZ)
Patients receive oral temozolomide.

Detailed Description:

This research study is a Phase III clinical trial. The purpose of this study is to compare the effectiveness of radiotherapy with temozolomide followed by temozolomide chemotherapy versus radiotherapy followed by PCV chemotherapy versus temozolomide chemotherapy alone in the treatment of anaplastic glioma. Patients are stratified according to cooperative group (EORTC vs North American groups [NCCTG, RTOG, CTSU, and NCIC CTG]), age (≤ 50 years vs > 50 years), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section below for more detailed information. The primary and secondary objectives are summarized below.

Objectives:

Primary Objective:

To determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) have a marginally better progression free survival (PFS) than patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV).

Secondary Objectives:

  1. Time to Progression - To determine whether patients who receive temozolomide (TMZ) alone have a significantly longer time to progression (neurocognitive, clinical or radiographic progression) than patients who receive radiotherapy with concomitant TMZ followed by adjuvant TMZ (RT + TMZ --> TMZ) or radiotherapy followed by PCV chemotherapy (RT --> PCV).
  2. Survival Difference - Determine whether there is a difference in survival based on translocation status and MGMT promoter hypermethylation status.
  3. Descriptive Comparisons of Additional Secondary Endpoints - Perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life.
  4. Toxicity - Determine the toxicity of the treatment in each arm and perform descriptive comparisons.
  5. Descriptive Determination of Timing of RT - Determine descriptively whether it is reasonable to delay RT in this patient cohort by documenting the time to progression and progression free survival of patients receiving temozolomide alone
  6. Neurocognitive and Quality of Life (QOL) Effects - Determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Pre-Registration Inclusion Criteria:

Central Pathology Review Submission This review is mandatory prior to registration to confirm eligibility. Patients must be willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible.

Registration Inclusion Criteria:

  1. Age ≥ 18 years
  2. Newly diagnosed and ≤ 3 months from surgical diagnosis
  3. Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III], as determined by pre-registration central pathology review. 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.
  4. Tumor is co-deleted for 1p and 19q.
  5. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior to registration. Patient must have recovered from the effects of surgery.
  6. The following laboratory values obtained ≤ 21 days prior to registration.

    1. Absolute neutrophil count (ANC) ≥ 1500/mm3
    2. Platelet (PLTs) count ≥ 100,000/mm3
    3. Hemoglobin (Hgb) > 9.0g/dL
    4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    5. Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x ULN
    6. Creatinine ≤ 1.5 x ULN
  7. Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only.
  8. Willing and able to complete neurocognitive testing without assistance and the Quality of Life (QOL) questionnaires with or without assistance
  9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  10. Provide informed written consent.
  11. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (ie, active treatment and observation portion of the study)
  12. Mandatory Tissue Samples for Correlative Research - Patient is willing to provide tissue samples for correlative research purposes

Registration Exclusion Criteria:

  1. Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of temozolomide treatments.
  2. Received any prior surgery, radiation therapy or chemotherapy for any central nervous system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or without surgery and who now have anaplastic glioma with no prior radiation or chemotherapy are eligible for the study.
  3. 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.
  4. Concomitant serious immunocompromised status (other than that related to concomitant steroids).
  5. Patients known to be Human Immunodeficiency Virus (HIV) positive and currently receiving retroviral therapy. Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study.
  6. 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.
  7. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  8. 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 must not be receiving other specific treatment (other than hormonal therapy) for their cancer.

  9. History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  10. Recent history of hepatitis infection or treating physician determined that the patient would be at significant risk of reactivation of hepatitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887146

  Hide Study Locations
Locations
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Jeanne Anderson, M.D.    907-562-0321      
United States, Arizona
Arizona Oncology-Deer Valley Center Recruiting
Phoenix, Arizona, United States, 85027
Contact: David Brachman, M.D.    602-240-3370      
Arizona Oncology Services Foundation Recruiting
Scottsdale, Arizona, United States, 85260
Contact: David Brachman, M.D.    602-240-3370      
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jethro Hu, M.D.    310-423-8100      
United States, Colorado
The Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Keren Sturtz, M.D.    303-777-2663      
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kurt Jaeckle, M.D.    904-953-7102      
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Lee Zehngebot, M.D.    407-898-5452      
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Priya Kumthekar, M.D.    312-908-5035      
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Edward Melian, M.D.    708-216-2729      
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, M.D.    515-956-2759      
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert Behrens, M.D.    515-244-7586      
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert Behrens, M.D.    515-244-7586      
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Robert Behrens, M.D.    515-244-7586      
Medical Oncology and Hematology Associates Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert Behrens, M.D.    515-244-7586      
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert Behrens, M.D.    515-244-7586      
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert Behrens, M.D.    515-244-7586      
Iowa Oncology Research Association CCOP Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert Behrens, M.D.    515-244-7586      
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, M.D.    859-323-8043      
United States, Michigan
Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex Mowat, M.D.    517-263-2507      
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert Chapman, M.D.    313-916-1784      
Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert Padula, M.D.    616-752-6218      
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert Padula, M.D.    616-752-6218      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond Lord, M.D.    269-373-7464      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert Padula, M.D.    616-752-6218      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick Flynn, M.D.    952-993-1517      
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick Flynn, M.D.    952-993-1517      
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Patrick Flynn, M.D.    952-993-1517      
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick Flynn, M.D.    952-993-1517      
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick Flynn, M.D.    952-993-1517      
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick Flynn, M.D.    952-993-1517      
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Patrick Flynn, M.D.    952-993-1517      
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55102
Contact: Patrick Flynn, M.D.    952-993-1517      
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Patrick Flynn, M.D.    952-993-1517      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kurt Jaeckle, M.D.    904-953-7102      
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick Flynn, M.D.    952-993-1517      
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick Flynn, M.D.    952-993-1517      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick Flynn, M.D.    952-993-1517      
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick Flynn, M.D.    952-993-1517      
Regions Hospital Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Patrick Flynn, M.D.    952-993-1517      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick Flynn, M.D.    952-993-1517      
Rice Memorial Hospital Recruiting
Wilmar, Minnesota, United States, 56201
Contact: Patrick Flynn, M.D.    (952) 993-1517      
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick Flynn, M.D.    952-993-1517      
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Nicole Shonka, M.D.    402-559-5520      
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Gamini Soori, M.D.    402-393-3110      
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Gamini Soori, M.D.    402-393-3110      
Missouri Valley Cancer Consortium CCOP Recruiting
Omaha, Nebraska, United States, 68106
Contact: Gamini Soori, M.D.    402-393-3110      
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Gamini Soori, M.D.    402-393-3110      
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: J. Marc Pipas, M.D.    603-650-9474      
United States, New York
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Yuhchyau Chen, M.D.    585-276-4543      
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen, M.D.    585-276-4543      
United States, North Dakota
Altru Cancer Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Grant Seeger, M.D.    701-780-5860      
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel Chao, M.D.    216-445-8776      
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Charles Nock, M.D.    216-844-3862      
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John Kuebler, M.D.    614-488-2118      
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John Kuebler, M.D.    614-488-2118      
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Arnab Chakravarti, M.D.    614-293-3241      
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John Kuebler, M.D.    614-488-2118      
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John Kuebler, M.D.    614-488-2118      
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence Herman, M.D.    405-271-3016      
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Wayne Pinover, M.D.    215-481-2800      
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Suresh Nair, M.D.    570-271-6045      
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Pierre Giglio, M.D.    843-792-6592      
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Andrews Recruiting
Greenville, South Carolina, United States, 29601
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: David Griselle, M.D.    864-241-6251      
Greenville Health System Cancer Institute/Greenville CCOP Recruiting
Greenville, South Carolina, United States, 29615
Contact: David Grisell, M.D.    864-241-6251      
Cancer Centers of the Carolinas-Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: David Grisell, M.D.    864-241-6251      
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: David Grisell, M.D.    864-241-6251      
United States, South Dakota
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Mark Schroeder, M.D.    605-719-2301      
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Paul Moots, M.D.    615-936-0216      
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Edward Pan, M.D.    214-645-8186      
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Martin Colman, M.D.    409-772-6723      
UTMB Cancer Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Martin Colman, M.D.    409-772-6723      
United States, Utah
Sandra L Maxwell Cancer Center Recruiting
Cedar City, Utah, United States, 84720
Contact: Jeffrey Lee, M.D.    801-507-3888      
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Jeffrey Lee, M.D.    801-507-3888      
Utah Valley Regional Medical Center Recruiting
Provo, Utah, United States, 84604
Contact: Jeffrey Lee, M.D.    801-507-3888      
Dixie Medical Center Regional Cancer Center Recruiting
Saint George, Utah, United States, 84770
Contact: Jeffrey Lee, M.D.    801-507-3888      
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Jeffrey Lee, M.D.    801-507-3888      
Utah Cancer Specialists-Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84106
Contact: Jeffrey Lee, M.D.    801-507-3888      
United States, Washington
PeaceHealth Saint Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Craig Nichols, M.D.    206-223-6193      
Virginia Mason CCOP Recruiting
Seattle, Washington, United States, 98101
Contact: Craig Nichols, M.D.    206-223-6193      
United States, Wisconsin
Gundersen Lutheran Health System/CCOP Recruiting
Crosse, Wisconsin, United States, 54601
Contact: Collin Driscoll, M.D.    (608) 782-7300      
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Joseph Bovi, M.D.    414-805-4474      
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Timothy Wassenaar, M.D.    262-928-2570      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
European Organisation for Research and Treatment of Cancer - EORTC
Radiation Therapy Oncology Group
Investigators
Study Chair: Kurt A. Jaeckle, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00887146     History of Changes
Other Study ID Numbers: NCCTG-N0577, NCI-2011-01915, EORTC-26081-22086, EudraCT-2008-007295-14, CDR0000640442
Study First Received: April 22, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Temozolomide
Procarbazine
Vincristine
Dacarbazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 14, 2014