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NCT00002569 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-06-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Radiation: radiation therapy
    label
    Radiation therapy (RT) alone
    type
    ACTIVE_COMPARATOR
  2. description
    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).
    intervention Names
    1. Drug: lomustine
    2. Drug: procarbazine hydrochloride
    3. Drug: vincristine sulfate
    4. Radiation: radiation therapy
    label
    Intensive pre-treatment chemotherapy and radiation therapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Intensive pre-treatment chemotherapy and radiation therapy
    name
    lomustine
    type
    DRUG
  2. arm Group Labels
    1. Intensive pre-treatment chemotherapy and radiation therapy
    name
    procarbazine hydrochloride
    type
    DRUG
  3. arm Group Labels
    1. Intensive pre-treatment chemotherapy and radiation therapy
    name
    vincristine sulfate
    type
    DRUG
  4. arm Group Labels
    1. Intensive pre-treatment chemotherapy and radiation therapy
    2. Radiation therapy (RT) alone
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
299
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
secondary Outcomes
  1. measure
    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.
  2. measure
    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.
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Cairncross JG, Wang M, Shaw EG, et al.: Chemotherapy plus radiotherapy (CT-RT) versus RT alone for patients with anaplastic oligodendroglioma: long-term results of the RTOG 9402 phase III study. [Abstract] J Clin Oncol 30 (Suppl 15): A-2008b, 2012.
    type
    RESULT
  2. citation
    Wang M, Cairncross G, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Mehta M, Curran W; Radiation Therapy Oncology Group (RTOG); North Central Cancer Treatment Group (NCCTG); Southwest Oncology Group (SWOG); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Eastern Cooperative Oncology Group (ECOG). Cognition and quality of life after chemotherapy plus radiotherapy (RT) vs. RT for pure and mixed anaplastic oligodendrogliomas: radiation therapy oncology group trial 9402. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):662-9. doi: 10.1016/j.ijrobp.2009.06.004. Epub 2009 Sep 23.
    pmid
    19783377
    type
    RESULT
  3. citation
    Giannini C, Burger PC, Berkey BA, Cairncross JG, Jenkins RB, Mehta M, Curran WJ, Aldape K. Anaplastic oligodendroglial tumors: refining the correlation among histopathology, 1p 19q deletion and clinical outcome in Intergroup Radiation Therapy Oncology Group Trial 9402. Brain Pathol. 2008 Jul;18(3):360-9. doi: 10.1111/j.1750-3639.2008.00129.x. Epub 2008 Mar 26.
    pmid
    18371182
    type
    RESULT
  4. citation
    Intergroup Radiation Therapy Oncology Group Trial 9402; Cairncross G, Berkey B, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperierre N, Mehta M, Curran W. Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402. J Clin Oncol. 2006 Jun 20;24(18):2707-14. doi: 10.1200/JCO.2005.04.3414.
    pmid
    16782910
    type
    RESULT
  5. citation
    Cairncross G, Seiferheld W, Shaw E, et al.: An intergroup randomized controlled clinical trial (RCT) of chemotherapy plus radiation (RT) versus RT alone for pure and mixed anaplastic oligodendrogliomas: initial report of RTOG 94-02. [Abstract] J Clin Oncol 22 (Suppl 14): A-1500, 107s, 2004.
    type
    RESULT
  6. citation
    Shaw EG, Seiferheld W, Cairncross JG, et al.: Radiation therapy (RT) alone vs intensive procarbazine-CCNU-vincristine (I-PCV) chemotherapy followed by radiation therapy for anaplastic oligodendroglioma (AO) and mixed oligo-astrocytoma (MOA): results of Radiation Therapy Oncology Group (RTOG) - intergroup protocol 94-02. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-57, S163, 2004.
    type
    RESULT
  7. citation
    Jenkins RB, Curran W, Scott CB, Cairncross G. Pilot evaluation of 1p and 19q deletions in anaplastic oligodendrogliomas collected by a national cooperative cancer treatment group. Am J Clin Oncol. 2001 Oct;24(5):506-8. doi: 10.1097/00000421-200110000-00018.
    pmid
    11586105
    type
    RESULT
  8. citation
    Lassman AB, Hoang-Xuan K, Polley MC, Brandes AA, Cairncross JG, Kros JM, Ashby LS, Taphoorn MJB, Souhami L, Dinjens WNM, Laack NN, Kouwenhoven MCM, Fink KL, French PJ, Macdonald DR, Lacombe D, Won M, Gorlia T, Mehta MP, van den Bent MJ. Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors. J Clin Oncol. 2022 Aug 10;40(23):2539-2545. doi: 10.1200/JCO.21.02543. Epub 2022 Jun 22.
    pmid
    35731991
    type
    DERIVED
  9. citation
    Cairncross G, Wang M, Shaw E, Jenkins R, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Curran W, Mehta M. Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol. 2013 Jan 20;31(3):337-43. doi: 10.1200/JCO.2012.43.2674. Epub 2012 Oct 15.
    pmid
    23071247
    type
    DERIVED
Source notices and limitations
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        q-deleted tumors.[<a href="#cit/section_4.23">23</a>]</li></ul></div></li><li>In contrast, the RTOG trial (<a href="/clinicaltrials/NCT00002569">RTOG-9402</a> [NCT00002569]) demonstrated no differences in median survival by treatment arm between an 8-week, intensive PCV chemotherapy regimen followed by immediate involved-field-pl
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      source update dates
      1. context
        Updated: March 28, 2025
        datetime
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice