NCT02710253

Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy

Phase II Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and best dose of radiation therapy and to see how well it works in treating patients with cancer that has spread to other places in the body (metastatic) or has increased in size after being treated with immunotherapy. Giving radiation therapy may help to control the cancer after the disease has gotten worse after receiving immunotherapy in patients with cancer that has spread to the other places in the body.

Detailed description

PRIMARY OBJECTIVES: I. To identify immunotherapy-based treatments where salvage radiation produces systemic disease control after initial progressive disease. II. To identify immunotherapy-based treatments where salvage radiation produces a high rate of treatment-related toxicities. SECONDARY OBJECTIVES: I. To determine the frequency of systemic disease control (objective response or stable disease) after salvage radiation following progression on immunotherapy among all patients and within each treatment group. II. Determine the frequency of dose limiting toxicities (DLTs) with salvage radiation after progression on treatment with an immunotherapy agent among all patients and within each treatment group. III. To determine the rate of systemic objective response among all patients and within each treatment group among all patients and within each treatment group. IV. To determine the duration of response in patients who achieve disease control among all patients and within each treatment group. V. To determine the overall survival after salvage radiation among all patients and within each treatment group. VI. To determine the systemic progression free survival after salvage radiation among all patients and within each treatment group. OUTLINE: Patients undergo either 4, 5, or 10 fractions of stereotactic body radiation therapy (SBRT), or 5-15 fractions of external beam radiation therapy (EBRT) to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least stable disease (SD) after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 1 year.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo EBRT
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2016-05-25
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2016-03-16
• Last updated: 2025-11-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study