NCT04530708

Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Swedish Lung Cancer Study Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.

Detailed description

Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization. Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements. Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).

Conditions

• Radiotherapy
• Non Small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer
• Quality of Life

Interventions

Type	Name	Description
RADIATION	Thoracic radiotherapy	36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.

Timeline

• Start date: 2017-02-01
• Primary completion: 2024-02-01
• Completion: 2026-02-01
• First posted: 2020-08-28
• Last updated: 2020-08-28

Locations

3 sites across 1 country: Sweden