Stereotactic Radiation Therapy With or Without Whole-Brain Radiation

Status Completed

Clinical Trial Summary

RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.

Clinical Trial Description

OBJECTIVES: Primary - Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary - Compare time to CNS (brain) failure in patients treated with these regimens. - Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens. - Compare post-treatment toxicity in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo stereotactic radiosurgery (SRS). - Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks. Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months. PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00377156
Study type	Interventional
Source	Alliance for Clinical Trials in Oncology
Contact
Status	Completed
Phase	Phase 3
Start date	July 2006
Completion date	December 15, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms