Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
84

Summary

Conditions
  • Male Breast Carcinoma
  • Prostate Adenocarcinoma
  • Recurrent Breast Carcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Recurrent Prostate Carcinoma
  • Stage IV Breast Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Prostate Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting. SECONDARY O...

PRIMARY OBJECTIVES: I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting. SECONDARY OBJECTIVES: I. To estimate rates of >= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases. II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT. III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery. OUTLINE: Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis. After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.

Tracking Information

NCT #
NCT02206334
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Chmura NRG Oncology