NCT00003375 · CITED IN SOURCE DOCUMENTS

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

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

Phase: PHASE2, PHASE3
Status at capture: COMPLETED
Registry last update: 2024-07-09

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.

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 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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Observation only.
label
Observation
type
NO_INTERVENTION
description
Radiation therapy only.
intervention Names
Radiation: radiation therapy
label
Radiation therapy
type
EXPERIMENTAL
description
Radiation and Procarbazine/CCNU/Vincristine (PCV) chemotherapy
intervention Names
Drug: lomustine
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
label
Radiation plus PCV chemotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
Radiation plus PCV chemotherapy
name
lomustine
type
DRUG
arm Group Labels
Radiation plus PCV chemotherapy
name
procarbazine hydrochloride
type
DRUG
arm Group Labels
Radiation plus PCV chemotherapy
name
vincristine sulfate
type
DRUG
arm Group Labels
Radiation plus PCV chemotherapy
Radiation therapy
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 370
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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 5 years or 80 deaths have been reported.

secondary Outcomes

measure
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.
measure
The severe or worse toxicities (>= grade 3) of unfavorable patients
time Frame
From start of treatment to end of follow-up

Full study description

brief Summary: 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.
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.

Source references

references

citation
Prabhu RS, Won M, Shaw EG, Hu C, Brachman DG, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta MP. Effect of the addition of chemotherapy to radiotherapy on cognitive function in patients with low-grade glioma: secondary analysis of RTOG 98-02. J Clin Oncol. 2014 Feb 20;32(6):535-41. doi: 10.1200/JCO.2013.53.1830. Epub 2014 Jan 13.
pmid
24419119
type
RESULT
citation
Shaw EG, Wang M, Coons SW, Brachman DG, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta MP. Randomized trial of radiation therapy plus procarbazine, lomustine, and vincristine chemotherapy for supratentorial adult low-grade glioma: initial results of RTOG 9802. J Clin Oncol. 2012 Sep 1;30(25):3065-70. doi: 10.1200/JCO.2011.35.8598. Epub 2012 Jul 30.
pmid
22851558
type
RESULT
citation
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. doi: 10.3171/JNS/2008/109/11/0835.
pmid
18976072
type
RESULT
citation
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.
type
RESULT
citation
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.
type
RESULT
citation
Bell EH, Zhang P, Shaw EG, Buckner JC, Barger GR, Bullard DE, Mehta MP, Gilbert MR, Brown PD, Stelzer KJ, McElroy JP, Fleming JL, Timmers CD, Becker AP, Salavaggione AL, Liu Z, Aldape K, Brachman DG, Gertler SZ, Murtha AD, Schultz CJ, Johnson D, Laack NN, Hunter GK, Crocker IR, Won M, Chakravarti A. Comprehensive Genomic Analysis in NRG Oncology/RTOG 9802: A Phase III Trial of Radiation Versus Radiation Plus Procarbazine, Lomustine (CCNU), and Vincristine in High-Risk Low-Grade Glioma. J Clin Oncol. 2020 Oct 10;38(29):3407-3417. doi: 10.1200/JCO.19.02983. Epub 2020 Jul 24.
pmid
32706640
type
DERIVED
citation
Buckner JC, Shaw EG, Pugh SL, Chakravarti A, Gilbert MR, Barger GR, Coons S, Ricci P, Bullard D, Brown PD, Stelzer K, Brachman D, Suh JH, Schultz CJ, Bahary JP, Fisher BJ, Kim H, Murtha AD, Bell EH, Won M, Mehta MP, Curran WJ Jr. Radiation plus Procarbazine, CCNU, and Vincristine in Low-Grade Glioma. N Engl J Med. 2016 Apr 7;374(14):1344-55. doi: 10.1056/NEJMoa1500925.
pmid
27050206
type
DERIVED