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
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
Secondary
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.
After completion of study therapy, patients are followed every 3-6 months for up to 5 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage IV disease
Oligometastatic disease (M1 with 1-3 metastases)
Previously untreated disease OR achieved stable disease or partial response within 8 weeks after completion of 2-6 courses of standard platinum-based chemotherapy (administered every 3-4 weeks)
Pleural effusion allowed provided it is minimal
No history of or current brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy ≥ 12 weeks
Platelet count ≥ 100,00/mm^3
Hemoglobin ≥ 9 g/dL
WBC ≥ 2,000/mm^3
Creatinine ≤ 2 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to undergo radiotherapy, based on radiation oncology consultation
Willing and able to comply with study treatment
FEV_1 ≥ 1 L
No requirement for daily supplemental oxygen
No second primary malignancy, except for any of the following:
No concurrent severe and/or uncontrolled medical condition, including any of the following:
No clinically significant infection
No psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
Hartford, Connecticut 06105, United States
Maywood, Illinois 60153, United States
Moline, Illinois 61265, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
St Louis, Missouri 63141, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Wright-Patterson AFB, Ohio 45433-5529, United States
Portland, Oregon 97213-2967, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States