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Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00033280
Collaborator
National Cancer Institute (NCI) (NIH), NRG Oncology (Other)
42
Enrollment
39
Locations
1
Arm
190.4
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.

  • Determine the toxicity of this regimen in these patients.

  • Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).

Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.

Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.

Patients with CR after completion of neoadjuvant temozolomide undergo observation.

Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
May 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pre-RT temozolomide, RT plus temozolomide

Pre-radiation therapy (RT) temozolomide, RT plus temozolomide

Drug: temozolomide

Procedure: neoadjuvant therapy

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

  1. Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) [From start of treatment to 6 months]

Secondary Outcome Measures

  1. Overall Survival [From registration to date of death or last follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma

  • Unifocal or multifocal disease

  • Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy

  • No equivocal oligodendroglial element

  • No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)

  • No spinal cord tumors

  • No evidence of spinal drop metastasis or spread to noncontiguous meninges

PATIENT CHARACTERISTICS:
Age:
  • 18 to 65
Performance status:
  • Zubrod 0-1
Life expectancy:
  • More than 12 weeks
Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3

  • Platelet count at least 100,000/mm^3

  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 2 times normal

  • Aspartate aminotransferase (AST) no greater than 3 times normal

  • Alkaline phosphatase no greater than 2 times normal

Renal:
  • Creatinine no greater than 1.5 times normal
Other:

  • No active infection

  • No other medical problems that would preclude study participation

  • No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:
Biologic therapy:
  • Not specified
Chemotherapy:

  • See Disease Characteristics

  • No prior chemotherapy for this malignancy

  • No prior temozolomide

Endocrine therapy:
  • Not specified
Radiotherapy:

  • See Disease Characteristics

  • No prior radiotherapy to the brain, head, or neck

Surgery:
  • At least 14 days since prior surgery requiring general anesthesia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mobile Infirmary Medical Center Mobile Alabama United States 36652-2144
2 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
3 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
4 Shands Cancer Center at the University of Florida Health Science Center Gainesville Florida United States 32610-0385
5 Mayo Clinic Jacksonville Florida United States 32224
6 University of Miami Sylvester Cancer Center Miami Florida United States 33136
7 Baptist Hospital of Miami Miami Florida United States 33256-2110
8 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
9 CCOP - Kansas City Kansas City Missouri United States 64131
10 Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha Omaha Nebraska United States 68114-4199
11 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
12 Wayne Memorial Hospital, Inc. Goldsboro North Carolina United States 27533
13 Rutherford Hospital Rutherfordton North Carolina United States 28139-0000
14 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
15 Akron City Hospital Akron Ohio United States 44304
16 Adena Regional Medical Center Chillicothe Ohio United States 45601
17 CCOP - Columbus Columbus Ohio United States 43206
18 Riverside Methodist Hospital Columbus Ohio United States 43214
19 Mount Carmel West Hospital Columbus Ohio United States 43222
20 Grady Memorial Hospital Delaware Ohio United States 43015
21 Fairfield Medical Center Lancaster Ohio United States 43130
22 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750-1635
23 Licking Memorial Hospital Newark Ohio United States 43055-2899
24 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
25 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
26 Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15219
27 Anderson Area Cancer Center Anderson South Carolina United States 29621-5705
28 Cottonwood Hospital Medical Center Murray Utah United States 84107
29 McKay-Dee Hospital Center Ogden Utah United States 84403
30 Utah Valley Regional Medical Center - Provo Provo Utah United States 84604
31 Dixie Regional Medical Center Saint George Utah United States 84770
32 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
33 LDS Hospital Salt Lake City Utah United States 84143
34 University Cancer Center at University of Washington Medical Center Seattle Washington United States 98195-6043
35 Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
36 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
37 CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
38 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
39 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2

Sponsors and Collaborators

  • Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology

Investigators

  • Study Chair: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00033280
Other Study ID Numbers:
  • RTOG-BR-0131
  • CDR0000069270
First Posted:
Jan 27, 2003
Last Update Posted:
Oct 22, 2020
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Radiation Therapy Oncology Group
adult anaplastic oligodendroglioma
adult mixed glioma
Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Oligodendroglioma
Temozolomide

Study Results

No Results Posted as of Oct 22, 2020