Adult Clinical Trials: BREAST, LUNG, AND PROSTATE

RTOG 0413: BREAST

A Phase III Study of Conventional Whole Breast Irradiation versus Partial Breast Irradiation for Women with Stage 0, 1 or 2 Breast Cancer
Treatment: 
Arm I:  WBI 45-50Gy in 25 fraction to whole breast followed by optional boost to 60Gy
Arm II: PBI: 34Gy in 3.4Gy fractions using multi-catheter brachytherapy or 34 Gy using MammoSite balloon catheter.

RTOG 0517: BREAST, LUNG, AND PROSTATE

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer

• Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration; appropriate diagnosis for protocol entry, based upon the diagnostic workup specified in the protocol
• 18 years of age; Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries
• Pregnancy test for women of childbearing potential within 2 weeks prior to registration
• All bisphosphonates other than the study drug must be discontinued prior to registration;
• patients with brain metastases and/or spinal cord compression are excluded
• Patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment
• No evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease
• No current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw .