Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborators:	National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group Eastern Cooperative Oncology Group NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002569

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	PHASE III INTERGROUP RANDOMIZED COMPARISON OF RADIATION ALONE VS PRE-RADIATION CHEMOTHERAPY FOR PURE AND MIXED ANAPLASTIC OLIGODENDROGLIOMAS

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Vincristine Lomustine Procarbazine hydrochloride Procarbazine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	292
Study Start Date:	July 1994

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.

Eligibility

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

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
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 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 CNS symptoms due to tumor-associated or radiotherapy-associated cerebral edema

Radiotherapy:

No prior radiotherapy to brain or head/neck

Surgery:

Prior surgery allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002569

Show 95 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Southwest Oncology Group

Eastern Cooperative Oncology Group

NCIC Clinical Trials Group

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Wang M, Cairncross G, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Mehta M, Curran W; on behalf of the 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. 2009 Sep 22; [Epub ahead of print]

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 Mar 26; [Epub ahead of print]

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.

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.

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.

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.

Study ID Numbers:	CDR0000063603, RTOG-9402, CAN-NCIC-CE2, E-R9402, NCCTG-927252, SWOG-9402, INT-0149
Study First Received:	November 1, 1999
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00002569 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult anaplastic oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Lomustine
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Alkylating Agents
Nervous System Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases

Mitosis Modulators
Vincristine
Antimitotic Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Tubulin Modulators
Oligodendroglioma
Procarbazine
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010