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

Sponsor
Wu Jieping Medical Foundation
Study ID
NCT01796288
Phase
PHASE2
Status
Unknown

Conditions

  • Non Small Cell Lung Cancer, Oligometastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • simultaneous radiotherapy — RADIATION
  • Erlotinib — DRUG

Study Details

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.

Key Dates

First listed
Feb 21, 2013
Start date
Oct 31, 2012
Status verified
Oct 2012
Primary completion
Apr 30, 2016
Completion
Oct 31, 2017

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib & simultaneous radiotherapy
    patients started simultaneously radiotherapy for all gross tumors
  • Other: Erlotinib & no radiotherapy
    patients received no radiotherapy for all gross tumors

Primary Outcome Measure

progession-free survival [ Time Frame: 3.5 year ]

Central Contacts