Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
|ClinicalTrials.gov Identifier: NCT00003375|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 17, 2018
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy||Phase 2 Phase 3|
- 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 (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||May 14, 2018|
No Intervention: Observation
Experimental: Radiation therapy
Radiation therapy only.
|Radiation: radiation therapy|
Experimental: Radiation plus PCV chemotherapy
Radiation and Procarbazine/CCNU/Vincristine (PCV) chemotherapy
|Drug: lomustine Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy|
- 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. ]
- 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. ]
- The severe or worse toxicities (>= grade 3) of unfavorable patients [ Time Frame: From start of treatment to end of follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003375
|Study Chair:||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|