Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

OBJECTIVES: I. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide. II. Compare the time to tumor progression in patients treated with these regimens. III. Compare the time to neuro-cognitive progression in patients treated with these regimens. IV. Compare the cause of death distribution in patients treated with these regimens. V. Compare the frequency of toxic effects of these regimens in these patients. VI. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00033254
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 3
Start date March 2002

See also
  Status Clinical Trial Phase
Completed NCT02107755 - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Completed NCT00098605 - Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases Phase 2
Completed NCT00072163 - Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Phase 2
Completed NCT01703507 - Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma Phase 1
Active, not recruiting NCT01706432 - Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer
Recruiting NCT01891318 - Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study Phase 1/Phase 2
Suspended NCT01843413 - Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases N/A
Completed NCT01276210 - Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases Phase 1
Completed NCT01234740 - Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases Phase 1
Completed NCT02312622 - Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer Phase 2
Terminated NCT00937482 - Cediranib Maleate and Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer Phase 1
Terminated NCT02269111 - Quantitative MRI in Assessing Disease in Patients With Brain Tumors N/A
Withdrawn NCT02277561 - Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery N/A
Completed NCT00992602 - Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer Phase 2
Withdrawn NCT02145910 - Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases Phase 1