NCT03481114

Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer

Patient-Reported Outcomes Following Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer: A Randomized Trial Comparing Two Radiotherapy Schedules

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment PET findings.

Detailed description

This study is open for patients with non-small cell lung cancer. This study offers such patients the chance for a shorter and more personalized treatment course utilizing PET imaging. Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans: 1. PET-based, dose-painted, accelerated chemoradiotherapy over 4 weeks (20 radiotherapy fractions) 2. Standard chemoradiotherapy over 6 weeks (30 radiotherapy fractions) All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians. All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a PRO-CTCAE tool.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PET-based, dose-painted, accelerated chemoradiotherapy	Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
COMBINATION_PRODUCT	Standard chemoradiotherapy	Patients in this arm will receive a standard radiotherapy course.

Timeline

• Start date: 2017-08-28
• Primary completion: 2023-07-05
• Completion: 2023-08-16
• First posted: 2018-03-29
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study