Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): lomustine; procarbazine hydrochloride; vincristine sulfate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Vincristine; Lomustine; Procarbazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult oligodendroglioma; adult diffuse astrocytoma; adult pilocytic astrocytoma