Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
- Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior
surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in
patients with good performance status and controlled systemic cancer.
- Determine overall survival and progression-free survival of patients treated on this
- Determine time to neurologic progression in patients treated on this protocol.
- Determine quality of life of patients treated on this protocol.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center, number of brain metastases (single vs multiple), type of primary tumor (stable
systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and
treatment (prior surgical resection vs planned radiosurgery).
Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment
arms within 4 weeks after surgery.
- Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
- Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo
radiosurgery are randomized to 1 of 2 treatment arms.
- Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after
- Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline,
at 8 weeks, and then every 3 months thereafter.
After completion if study treatment, patients are followed at 8 weeks and then every 3
PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this
study within 3.5 years.
Allocation: Randomized, Primary Purpose: Treatment
Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
Rolf-Peter Mueller, MD
Medizinische Universitaetsklinik I at the University of Cologne
United States: Federal Government