NCT02206334

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.

Detailed 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 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.

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

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Undergo SBRT

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-06-01
• Completion: 2022-05-20
• First posted: 2014-08-01
• Last updated: 2022-05-25

Locations

78 sites across 3 countries: United States, Canada, Switzerland