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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Patients undergo observation for 6 weeks.
Patients undergo radiotherapy 5 days a week for 6 weeks.
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
Overall Survival
Overall survival was defined as the time from registration to the date of death or last follow-up
Time frame: Time from registration to death or last follow-up (up to 5 years)
Response Rate
A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.
Time frame: Up to 5 years
Progression-free Survival
Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.
Time frame: Time from registration to disease progression or death (up to 5 years)
Time to Disease Progression
Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Time frame: Time from registration to disease progression (up to 5 years)
Time to Treatment Failure
Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.
Time frame: Up to 5 years
Duration of Response
Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.
Time frame: Up to 5 years
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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
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