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Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma Clinical research trials and Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma clinical trial. Human subjects often get the best healthcare available for their Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma  Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
For Condition: Adult Oligodendroglioma,adult infiltrating astrocytoma,adult noninfiltrating astrocytoma
Status: No longer recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI),Southwest Oncology Group,North Central Cancer Treatment Group,Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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 radiation therapy with or without procarbazine, lomustine, and vincristine (PCV) chemotherapy. - Compare the toxic effects of postoperative radiation therapy 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] versus oligodendroglioma [mixed-oligo dominant]), age (younger than 40 versus at least 40), Karnofsky performance status (60-80 versus 90-100), and contrast enhancement on preoperative scan (present versus absent). Patients who are assessed to be at low risk (younger than 40 years old whose tumors have been surgically removed) are observed in arm I. Patients may receive treatment if tumor recurs. Patients who are assessed to be at high risk (at least 40 years old or who have had incomplete tumor removal) are randomized to either arm II or III. In arm II, patients receive daily external beam radiation therapy 5 days a week for 6 weeks. In arm III, patients receive radiation therapy as in arm II followed by chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1, an intravenous injection of vincristine on days 8 and 29, and oral procarbazine on days 8-21. Each course of chemotherapy lasts 8 weeks. Patients may receive up to six courses of chemotherapy. Patients are followed every 4 months for 1 year, then every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 252 patients will be accrued over 5 years at a rate of 4 patients per month.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 1500/mm3 - Platelet count within normal range Hepatic: - For high risk patients: - Bilirubin no greater than 2 times normal - SGOT or SGPT no greater than 2 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 concurrent malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer - No prior malignancies except those that have been in remission for at least 5 years - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiation therapy to the head or neck (unless radiation clearly excludes the brain, such as radiation for localized vocal cord cancer) Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardShaw, Study Chair, Comprehensive Cancer Center of Wake Forest University
Additional Information:
Study ID Numbers: CDR0000066367; RTOG-9802,E-R9802,NCCTG-R9802,SWOG-R9802,RTOG-DEV-1012
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003375
Other Adult Oligodendroglioma Studies:
1. Imatinib Mesylate in Treating Patients With Gliomas
2. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
3. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
4. Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
5. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
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Other Adult Oligodendroglioma Clinical Trials
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Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
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