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

October 15, 2020 updated by: Radiation Therapy Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Observation only.
Experimental: Radiation therapy
Radiation therapy only.
Radiation: radiation therapy
Experimental: Radiation plus PCV chemotherapy
Radiation and Procarbazine/CCNU/Vincristine (PCV) chemotherapy
Radiation: radiation therapy
Drug: vincristine sulfate
Drug: lomustine
Drug: procarbazine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported.
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival
Time Frame: From randomization to the date of progression, death or last follow-up. Analysis ours at the same time as the primary outcome analysis.
From randomization to the date of progression, death or last follow-up. Analysis ours at the same time as the primary outcome analysis.
The severe or worse toxicities (>= grade 3) of unfavorable patients
Time Frame: From start of treatment to end of follow-up
From start of treatment to end of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)
NRG Oncology
Eastern Cooperative Oncology Group
Southwest Oncology Group
North Central Cancer Treatment Group

Investigators

  • Study Chair: Minesh P. Mehta, MD, University of Wisconsin, Madison
  • Study Chair: Geoffrey R. Barger, MD, Barbara Ann Karmanos Cancer Institute
  • Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-9802
  • CDR0000066367
  • E-R9802
  • NCCTG-R9802
  • SWOG-R9802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain and Central Nervous System Tumors

Clinical Trials on radiation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe