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

NCT01796288 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-02-21

No results posted yet for this study

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

RADIATION

simultaneous radiotherapy

DRUG

Erlotinib

Sponsors & Collaborators

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Anhui Medical University

    collaborator OTHER

  • Wuxi No. 4 People's Hospital

    collaborator OTHER

  • Wu Jieping Medical Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-04-30
Completion
2017-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796288 on ClinicalTrials.gov