NCT01796288

The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment

The Value of Radiotherapy in the Oligometastatic Non-squamous Non-small Cell Lung Cancer With Clinical Benefits From Erlotinib as Second-line Treatment: a Randomized Controlled Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Wu Jieping Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a multi-center randomized controlled Phase II clinical trial. Patients with oligometastatic stage IV (number of distant metastases ≤ 5) non-squamous non-small cell lung cancer treated with second-line erlotinib150mg daily for 3 months with clinical benefits (free-from progression) were randomized (stratified according to smoking status and different research centers) to the radiotherapy group (n = 100) and the non-radiotherapy group (n = 100). Radiotherapy group (experimental group) patients started simultaneously radiotherapy for all gross tumors soon after randomization; non-radiotherapy group (control group) received no radiotherapy for all gross tumors. Erlotinib was continuously used until to disease progression or unbearable adverse effect, and the subsequently further salvage therapies were determined by the investigators. The primary endpoint was PFS.

Conditions

• Non Small Cell Lung Cancer, Oligometastatic

Interventions

Type	Name	Description
RADIATION	simultaneous radiotherapy
DRUG	Erlotinib

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-04-01
• Completion: 2017-10-01
• First posted: 2013-02-21
• Last updated: 2013-02-21

Locations

1 site across 1 country: China