Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Other: clinical observationRadiation: radiation therapy
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I clinical observation Patients undergo observation for 6 weeks. Arm II radiation therapy Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
- 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)
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Lahey Clinic Medical Center - Burlington
🇺🇸Burlington, Massachusetts, 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 - Eureka
🇺🇸Eureka, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare - Galesburg
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare - Havana
🇺🇸Havana, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Illinois CancerCare - Macomb
🇺🇸Macomb, Illinois, United States
OSF Holy Family Medical Center
🇺🇸Monmouth, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Illinois CancerCare - Monmouth
🇺🇸Monmouth, Illinois, United States
Illinois CancerCare - Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Illinois CancerCare - Peru
🇺🇸Peru, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Illinois CancerCare - Princeton
🇺🇸Princeton, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸Clive, Iowa, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Adventist Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Illinois CancerCare - Bloomington
🇺🇸Bloomington%, Illinois, United States
Illinois CancerCare - Carthage
🇺🇸Carthage, Illinois, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Illinois CancerCare - Canton
🇺🇸Canton, Illinois, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States