Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non -Small Cell Lung Cancer
- Quality of Life
- Radiotherapy
- Stage IV Non-small Cell Lung Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicentre randomized phase 3 trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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).
Tracking Information
- NCT #
- NCT04530708
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jan Nyman, Ass.prof Sahlgrenska University Hospital, Sweden Study Director: Thomas Björk-Eriksson, Prof. Regionalt Cancercentrum Väst