Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Recruitment status was Active, not recruiting
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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 2 Phase 3 |
| 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 |
| Estimated Enrollment: | 252 |
| Study Start Date: | October 1998 |
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 |
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| 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:
Publications:
| 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: | August 9, 2012 |
| 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 June 17, 2013