Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
First received: October 4, 2000
Last updated: November 14, 2015
Last verified: November 2015

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: tamoxifen citrate
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratentorial Glioblastoma Multiforme (GBM)

Resource links provided by NLM:

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: December 2000
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation plus Tamoxifen Drug: tamoxifen citrate Radiation: radiation therapy

Detailed Description:

OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.


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

DISEASE CHARACTERISTICS: Histologically proven newly diagnosed, supratentorial glioblastoma multiforme (with areas of necrosis) Diagnosis must be made by surgical biopsy or excision within the past 5 weeks No recurrent malignant gliomas No metastases below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 70-100% OR Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Hematocrit at least 30% (transfusion allowed) Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Cardiovascular: No active thrombophlebitis Other: Recovered from any postoperative infection or other complications No major medical illnesses or psychiatric impairments that would preclude study participation No active connective tissue disorder, such as lupus or scleroderma No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder No prior endometrial cancer or atypical endometrial hyperplasia No AIDS Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 12 months since prior tamoxifen Radiotherapy: See Disease Characteristics No prior radiotherapy to head or neck Surgery: See Disease Characteristics Recovered from prior surgery

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006388

  Show 257 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: H. I. Robins, MD, PhD University of Wisconsin, Madison
  More Information

Robins HI, Won M, Schultz C, et al.: A phase II trial of conventional radiation therapy (XRT) plus high dose tamoxifen (TAM) for the treatment of supratentorial glioblastoma multiforme (GBM): RTOG protocol BR-0021. [Abstract] J Clin Oncol 22 (Suppl 14): A-1529, 114s, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00006388     History of Changes
Other Study ID Numbers: RTOG-BR-0021  CDR0000068266  RTOG-DEV-1015 
Study First Received: October 4, 2000
Last Updated: November 14, 2015
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
Nervous System 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
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 26, 2016