NCT00003375

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1998

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
12.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

6.8 years

First QC Date

November 1, 1999

Last Update Submit

July 8, 2024

Conditions

Brain and Central Nervous System Tumors

Keywords

adult oligodendrogliomaadult diffuse astrocytomaadult pilocytic astrocytoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    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 (2)

  • Progression-free Survival

    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

    From start of treatment to end of follow-up

Study Arms (3)

Observation

NO INTERVENTION

Observation only.

Radiation therapy

EXPERIMENTAL

Radiation therapy only.

Radiation: radiation therapy

Radiation plus PCV chemotherapy

EXPERIMENTAL

Radiation and Procarbazine/CCNU/Vincristine (PCV) chemotherapy

Drug: lomustineDrug: procarbazine hydrochlorideDrug: vincristine sulfateRadiation: radiation therapy

Interventions

lomustineDRUG
Radiation plus PCV chemotherapy
procarbazine hydrochlorideDRUG
Radiation plus PCV chemotherapy
vincristine sulfateDRUG
Radiation plus PCV chemotherapy
radiation therapyRADIATION
Radiation plus PCV chemotherapyRadiation therapy

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (7)

  • 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: 24419119RESULT

  • 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: 22851558RESULT

  • 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: 18976072RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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: 32706640DERIVED

  • 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: 27050206DERIVED

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsOligodendrogliomaAstrocytoma

Interventions

LomustineProcarbazineVincristineRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsBenzamidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeutics

Study Officials

  • Edward G. Shaw, MD

    Wake Forest University Health Sciences

    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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1998

Primary Completion

August 1, 2005

Study Completion

May 14, 2018

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive