Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2002 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 1, 1999. Last Updated on June 23, 2011 History of Changes

Sponsor:	Radiation Therapy Oncology Group
Collaborators:	National Cancer Institute (NCI) Southwest Oncology Group North Central Cancer Treatment Group Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003375

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma.

PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma

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:	252
Study Start Date:	October 1998

Detailed Description:

OBJECTIVES:

Identify the overall survival of low-risk adult patients with supratentorial low-grade glioma who are observed postoperatively.
Compare the overall survival of high-risk adult patients with supratentorial low-grade glioma who receive postoperative external beam radiotherapy with or without procarbazine, lomustine, and vincristine (PCV) chemotherapy.
Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy in patients with unfavorable low-grade glioma.

OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent). Patients with low-risk disease (younger than 40 years old whose tumors have been surgically removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who have had incomplete tumor removal) are randomized to arm II or III.

Arm I (low-risk patients): Patients are observed. Patients may receive treatment if tumor recurs.
Arm II (high-risk patients): Patients receive daily external beam radiotherapy 5 days a week for 6 weeks.
Arm III (high-risk patients): Patients receive radiotherapy as in arm II followed by chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Each course of chemotherapy lasts 8 weeks. Patients may receive up to 6 courses of chemotherapy.

Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed unifocal or multifocal supratentorial WHO grade II astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic), oligodendroglioma, or oligoastrocytoma
Patients with neurofibromatosis are eligible
No other low-grade histologies, including:
- Pilocytic astrocytoma
- Subependymal giant cell astrocytoma of tuberous sclerosis
- Subependymoma
- Pleomorphic xanthoastrocytoma
- Presence of a neuronal element such as ganglioglioma
- Dysneuroembryoplastic epithelial tumor
No presence of any high-grade glioma, including:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
No tumors in nonsupratentorial or other locations including optic chiasm, optic nerve(s), pons, medulla, cerebellum, or spinal cord
No evidence of spread to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis)
No gliomatosis cerebri

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Hematopoietic:

For high-risk patients:
- Granulocyte count at least 1,500/mm^3
- Platelet count normal

Hepatic:

Bilirubin no greater than 2 times normal
SGOT or SGPT no greater than 4 times normal
Alkaline phosphatase no greater than 2 times normal

Renal:

Creatinine no greater than 2 times normal

Pulmonary:

No chronic lung disease (unless DLCO at least 60%)

Neurological:

Neurologic function score no greater than 3

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as radiotherapy for localized vocal cord cancer)

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003375

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Southwest Oncology Group

North Central Cancer Treatment Group

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Edward G. Shaw, MD	Comprehensive Cancer Center of Wake Forest University
Study Chair:	Geoffrey R. Barger, MD	Barbara Ann Karmanos Cancer Institute
Study Chair:	Jan C. Buckner, MD	Mayo Clinic
Study Chair:	Minesh P. Mehta, MD	University of Wisconsin, Madison

More Information

Additional Information:

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

Publications:

Shaw EG, Berkey B, Coons SW, Bullard D, Brachman D, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta M. Recurrence following neurosurgeon-determined gross-total resection of adult supratentorial low-grade glioma: results of a prospective clinical trial. J Neurosurg. 2008 Nov;109(5):835-41.

Shaw EG, Wang S, Coons S, et al.: Final report of Radiation Therapy Oncology Group (RTOG) protocol 9802: radiation therapy (RT) versus RT + procarbazine, CCNU, and vincristine (PCV) chemotherapy for adult low-grade glioma (LGG). [Abstract] J Clin Oncol 26 (Suppl 15): A-2006, 2008.

Shaw EG, Berkey B, Coons SW, et al.: Initial report of Radiation Therapy Oncology Group (RTOG) 9802: prospective studies in adult low-grade glioma (LGG). [Abstract] J Clin Oncol 24 (Suppl 18): A-1500, 2006.

ClinicalTrials.gov Identifier:	NCT00003375 History of Changes
Other Study ID Numbers:	CDR0000066367, RTOG-9802, E-R9802, NCCTG-R9802, SWOG-R9802, RTOG-DEV-1012
Study First Received:	November 1, 1999
Last Updated:	June 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult oligodendroglioma
adult diffuse astrocytoma
adult pilocytic astrocytoma

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
Lomustine

Procarbazine
Vincristine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012