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Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
This study has been completed.

First Received on April 9, 2002.   Last Updated on August 29, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033254
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases.


Condition Intervention Phase
Metastatic Cancer
Drug: thalidomide
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Study Of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy For Multiple Brain Metastases

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
  • Compare the time to tumor progression in patients treated with these regimens.
  • Compare the time to neuro-cognitive progression in patients treated with these regimens.
  • Compare the cause of death distribution in patients treated with these regimens.
  • Compare the frequency of toxic effects of these regimens in these patients.
  • Evaluate and compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
  • Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily. Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.

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

PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed extracranial primary malignancy
  • Multiple brain metastases
  • At least 1 measurable brain metastasis by MRI

    • More than 4.0 cm OR
    • Located in midbrain or brainstem (radiosurgery ineligible)

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-1

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 11 g/dL*
  • Hematocrit at least 35%* NOTE: * Transfusion and/or epoetin alfa allowed

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • BUN no greater than 25 mg/dL

Cardiovascular:

  • No history of deep venous thrombosis

Other:

  • No sensory neuropathy grade 2 or greater
  • No known AIDS
  • No other major medical illness or psychiatric impairments that would preclude study therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior thalidomide

Chemotherapy:

  • More than 2 weeks since prior chemotherapy
  • Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the head or neck
  • No prior radiosurgery

Surgery:

  • Prior resection of brain metastases allowed

Other:

  • No concurrent anticoagulant therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033254

  Show 258 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Jonathan P. S. Knisely, MD, FRCPC Yale University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00033254     History of Changes
Other Study ID Numbers: CDR0000069268, RTOG-BR-0118, RTOG-DEV-1006
Study First Received: April 9, 2002
Last Updated: August 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012