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A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
OBJECTIVES: Primary * To assess whether the addition of radiotherapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival of patients with oligometastatic stage IV non-small cell lung cancer. Secondary * To compare the progression-free survival of patients treated with radiotherapy vs observation after standard chemotherapy. * To compare the time to disease progression and time to treatment failure in these patients. * To compare the confirmed response rate in these patients. * To compare the duration of response in these patients. * To compare the adverse events in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with bevacizumab during first-line chemotherapy (yes vs no), number of standard chemotherapy courses (2-3 vs 4-6), Linear Analog Self Assessment value (≤ 7 vs \> 7), and histology (predominantly squamous cell vs not predominantly squamous cell). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo observation for 6 weeks. * Arm II: Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease. After completion of study therapy, patients are followed every 3-6 months for up to 5 years.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Start Date
October 1, 2008
Primary Completion Date
September 1, 2010
Completion Date
September 1, 2010
Last Updated
March 6, 2017
3
ACTUAL participants
clinical observation
OTHER
radiation therapy
RADIATION
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05198830
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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