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Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma

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ClinicalTrials.gov Identifier: NCT00003375
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):

November 1, 1999
January 27, 2003
September 29, 2016
October 1998
August 2005   (Final data collection date for primary outcome measure)
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. ]
Not Provided
Complete list of historical versions of study NCT00003375 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
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Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
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

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.


  • 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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
  • No Intervention: Observation
    Observation only.
  • Experimental: Radiation therapy
    Radiation therapy only.
    Intervention: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
August 2005   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%


  • For high-risk patients:

    • Granulocyte count at least 1,500/mm^3
    • Platelet count normal


  • Bilirubin no greater than 2 times normal
  • SGOT or SGPT no greater than 4 times normal
  • Alkaline phosphatase no greater than 2 times normal


  • Creatinine no greater than 2 times normal


  • No chronic lung disease (unless DLCO at least 60%)


  • Neurologic function score no greater than 3


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as radiotherapy for localized vocal cord cancer)


  • Not specified
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
  • North Central Cancer Treatment Group
  • Eastern Cooperative Oncology Group
  • NRG Oncology
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
Radiation Therapy Oncology Group
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP