Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Phase 2

Terminated

Conditions: Lung Cancer

Registration Number: NCT00776100

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival	Time from registration to death or last follow-up (up to 5 years)	Overall survival was defined as the time from registration to the date of death or last follow-up

Secondary Outcome Measures

Name	Time	Method
Response Rate	Up to 5 years	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.
Progression-free Survival	Time from registration to disease progression or death (up to 5 years)	Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.
Time to Disease Progression	Time from registration to disease progression (up to 5 years)	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 to Treatment Failure	Up to 5 years	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.
Duration of Response	Up to 5 years	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.

Trial Locations

Locations (165): 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
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Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States