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Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003417
First received: November 1, 1999
Last updated: July 17, 2013
Last verified: September 2003
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Estimated Enrollment: 40
Study Start Date: September 1998
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme.
  • Determine dose/volume and dose/anatomic characteristics that influence radiotherapy-induced CNS (central nervous system) toxicity.
  • Evaluate local control, survival, and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease.
  • Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints.

OUTLINE: This is a dose-escalation study. Patients are stratified according to the planned target volume, i.e., gross residual tumor plus 3 mm (less than 75 cc vs at least 75 cc).

Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks. After 46 Gy of radiotherapy have been administered, patients undergo radiotherapy field reduction and are accrued into one of four dose levels. (Dose level 1 closed to accrual 1/16/01) All patients receive at least 33 radiation treatments. Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy.

Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy. Treatment repeats every 8 weeks for up to 6 courses.

Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within at least 5 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision

    • Supratentorial tumor
  • Gross measurable residual disease
  • No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme
  • Therapy must begin within 5 weeks after surgery but within 1 week after registration
  • CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy

    • If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning
  • Prior complete surgical resection of tumor allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 2 mg/dL
  • SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal

Renal:

  • BUN (blood urea nitrogen) no greater than 30 mg/dL
  • Creatinine no greater than 1.8 mg/dL

Pulmonary:

  • Normal chest x-ray OR
  • DLCO (carbon monoxide diffusing capacity) at least 60% predicted

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer
  • Neurologic functional status 0-3
  • No major medical illness or psychiatric impairments that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to head or neck

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003417

  Show 237 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Jeff M. Michalski, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Publications:
Fox W, Berkey B, Michalski J, et al.: Health-related quality of life and cognitive status in patiens with glioblastoma multiforme receiving escalating doses of comformal three-dimensional radiation on RTOG 9803. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppll 1): A-128, S78, 2005.
Werner-Wasik M, Seiferheld W, Michalski J, et al.: Phase I/II conformal three-dimensional radiation therapy dose escalation study in patients with supratentorial glioblastoma multiforme: report of the Radiation Therapy Oncology Group 98-03 protocol. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-58, S163-4, 2004. Available online. Last accessed January 27, 2005.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003417     History of Changes
Other Study ID Numbers: RTOG-9803, CDR0000066432
Study First Received: November 1, 1999
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 27, 2014