E6397 – Trial Results Summary for Patients

Title

Radiosurgery Alone in Treating Patients with Newly Diagnosed Brain Metastases from Kidney Cancer, Melanoma or Sarcoma (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

To find out whether a single, targeted, high-dose radiation treatment, known as radiosurgery, without the standard treatment, whole brain radiotherapy (WBRT), can control the current and future growth of tumors in the brain that have metastasized (spread) from kidney cancer, melanoma or sarcoma.

Results

Complete and partial response, the incidences of brain tumors which got smaller by at least 50 percent or became undetectable, were experienced by 10 percent of participants in this trial. After six months, 32.2 percent of patients had experienced growth of tumor in the area treated with radiosurgery and 32.2 percent also had growth of the tumor in areas of the brain which did not receive radiosurgery. Median survival, when half the patients in a trial are still living, is one measure of the effectiveness of a treatment. In this study, median survival was 8.3 months. Investigators concluded that radiosurgery without the standard therapy (WBRT) should be used with caution outside a clinical trial and that a larger phase III study could be appropriate.

Conclusion

This study established, in a prospective fashion, that intracranial relapse is frequent with avoidance of whole brain radiotherapy. Whether inclusion of it would alter relapse patterns and patient outcomes remains an important question for future study.

Start Date

July 1998

Stop Date

August 2003

Number of Participating Patients

36

Eligibility Requirements

Patients were at least 18 years old, had confirmed renal cell carcinoma, melanoma or sarcoma, with one to three newly-diagnosed brain metastases (cancer spread to the brain). They had no history of multiple liver metastases, no previous radiation therapy to the head, and no previous surgery for brain metastases.

Study Design

Patients received a one-time radiation treatment. Before the radiation was delivered, the patient’s head was immobilized in a frame, held in place with pins inserted using local anesthesia and sedation. A CT or MRI scan was done and the images used to plan the treatment. The radiation, precisely targeted to the areas of tumor, was then delivered and the frame removed. Each patient received ongoing monitoring and follow-up care appropriate to his/her condition.

Side Effects

Side effects were mostly mild and included headache and nausea,, fatigue, lowered blood counts, and seizures.

Additional Information at ClinicalTrials.gov

NCT00003308