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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003375
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE October 1998
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
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. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: lomustine
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
    • Radiation: radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
370
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 14, 2018
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003375
Other Study ID Numbers  ICMJE RTOG-9802
CDR0000066367
E-R9802
NCCTG-R9802
SWOG-R9802
RTOG-DEV-1012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
  • North Central Cancer Treatment Group
  • Eastern Cooperative Oncology Group
  • NRG Oncology
Investigators  ICMJE
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
PRS Account Radiation Therapy Oncology Group
Verification Date May 2018

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