NCT01664663

Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Ass. Prof. Jan Nyman · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

Detailed description

This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Conditions

• Non Small Cell Lung Cancer
• Locally Advanced Disease

Interventions

Type	Name	Description
RADIATION	Standard radiochemotherapy to 68 Gy
RADIATION	Dose escalated radiochemotherapy up to 84 Gy

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-11-01
• Completion: 2015-10-01
• First posted: 2012-08-14
• Last updated: 2014-12-09

Locations

3 sites across 1 country: Sweden