Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002569
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013

November 1, 1999
September 27, 2013
July 1994
February 2005   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002569 on ClinicalTrials.gov Archive Site
  • Time to tumor progression [ Time Frame: From randomization to date of progression or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
  • Frequency of severe (>= Grade 3) toxicities [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.

OBJECTIVES:

  • Compare the overall survival and time to tumor progression in patients with unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).
  • Compare the toxic effects of these 2 regimens in these patients.
  • Compare the quality of life and neurologic function of patients treated with these 2 regimens.

OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a week for 1 week.
  • Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of study therapy.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study within 5.4 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
  • Active Comparator: Radiation therapy (RT) alone
    Radiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.
    Intervention: Radiation: radiation therapy
  • Experimental: Intensive pre-treatment chemotherapy and radiation therapy
    Intensive pre-treatment chemotherapy (Day 1 CCNU 130 mg/m2 p.o., Day 8 - Vincristine 1.4 mg/m2 i.v., Days 8-21 - Procarbazine 75 mg/m2 p.o., Day 29 - Vincristine 1.4 mg/m2 i.v.) followed by radiation therapy (External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume).
    Interventions:
    • Drug: lomustine
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
    • Radiation: radiation therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
Not Provided
February 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma

    • Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma
  • Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation

    • For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic
  • No evidence of spinal drop metastasis or spread to noncontiguous meninges

    • MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor
  • No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
  • No spinal cord tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times normal
  • Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Pulmonary:

  • No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted

Other:

  • No active infection
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No concurrent steroids as antiemetics
  • Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema

Radiotherapy:

  • No prior radiotherapy to brain or head/neck

Surgery:

  • Prior surgery allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002569
RTOG-9402, CDR0000063603, CAN-NCIC-CE2, E-R9402, NCCTG-927252, SWOG-9402, INT-0149
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • North Central Cancer Treatment Group
  • Southwest Oncology Group
  • Eastern Cooperative Oncology Group
  • NCIC Clinical Trials Group
Study Chair: J. Gregory Cairncross, MD London Regional Cancer Program at London Health Sciences Centre
Study Chair: Steven R. Alberts, MD Mayo Clinic
Study Chair: Karen L. Fink, MD, PhD Simmons Cancer Center
Study Chair: Richard M. Hellman, MD Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Study Chair: Normand Laperriere, MD, FRCPC Princess Margaret Hospital, Canada
Radiation Therapy Oncology Group
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP