- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00776100
Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna, 85259-5499
- Mayo Clinic Scottsdale
-
-
Connecticut
-
Hartford, Connecticut, Förenta staterna, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Bloomington%, Illinois, Förenta staterna, 61701
- Illinois CancerCare - Bloomington
-
Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare - Canton
-
Canton, Illinois, Förenta staterna, 61520
- Graham Hospital
-
Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare - Carthage
-
Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare - Eureka
-
Eureka, Illinois, Förenta staterna, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare - Galesburg
-
Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Clinic, PC
-
Galesburg, Illinois, Förenta staterna, 61401
- InterCommunity Cancer Center of Western Illinois
-
Havana, Illinois, Förenta staterna, 62644
- Mason District Hospital
-
Havana, Illinois, Förenta staterna, 62644
- Illinois CancerCare - Havana
-
Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare - Macomb
-
Macomb, Illinois, Förenta staterna, 61455
- Mcdonough District Hospital
-
Maywood, Illinois, Förenta staterna, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Moline, Illinois, Förenta staterna, 61265
-
Moline, Illinois, Förenta staterna, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth, Illinois, Förenta staterna, 61462
- Illinois CancerCare - Monmouth
-
Monmouth, Illinois, Förenta staterna, 61462
- OSF Holy Family Medical Center
-
Normal, Illinois, Förenta staterna, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Förenta staterna, 61761
- Community Cancer Center
-
Normal, Illinois, Förenta staterna, 61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa, Illinois, Förenta staterna, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Förenta staterna, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
-
Peoria, Illinois, Förenta staterna, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Förenta staterna, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare - Peru
-
Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Förenta staterna, 61356
- Perry Memorial Hospital
-
Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare - Princeton
-
Spring Valley, Illinois, Förenta staterna, 61362
- Valley Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, Förenta staterna, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital & Health Care Services
-
-
Iowa
-
Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic, PC
-
Bettendorf, Iowa, Förenta staterna, 52722
-
Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Des Moines, Iowa, Förenta staterna, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Mason City, Iowa, Förenta staterna, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Förenta staterna, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, Förenta staterna, 67901
- Southwest Medical Center
-
Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas, PA - Salina
-
Topeka, Kansas, Förenta staterna, 66606
- Cotton-O'Neil Cancer Center
-
Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Förenta staterna, 67214
- Wesley Medical Center
-
Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
-
Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, Förenta staterna, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Massachusetts
-
Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Clinic Medical Center - Burlington
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, Förenta staterna, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Jackson, Michigan, Förenta staterna, 49201
- Foote Memorial Hospital
-
Lansing, Michigan, Förenta staterna, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, Förenta staterna, 48154
- St. Mary Mercy Hospital
-
Pontiac, Michigan, Förenta staterna, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, Förenta staterna, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, Förenta staterna, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Warren, Michigan, Förenta staterna, 48093
- St. John Macomb Hospital
-
-
Minnesota
-
Bemidji, Minnesota, Förenta staterna, 56601
- MeritCare Bemidji
-
Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Förenta staterna, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, Förenta staterna, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale, Minnesota, Förenta staterna, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Cancer Center
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Shakopee, Minnesota, Förenta staterna, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
St. Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Mississippi
-
Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Cancer Clinic
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Förenta staterna, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
-
Springfield, Missouri, Förenta staterna, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Förenta staterna, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Förenta staterna, 65807
- Hulston Cancer Center at Cox Medical Center South
-
-
Montana
-
Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Förenta staterna, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Förenta staterna, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Förenta staterna, 59107-7000
- Billings Clinic - Downtown
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Förenta staterna, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Förenta staterna, 59405
-
Great Falls, Montana, Förenta staterna, 59405-5309
- Big Sky Oncology
-
Great Falls, Montana, Förenta staterna, 59405
- Sletten Cancer Institute at Benefis Healthcare
-
Havre, Montana, Förenta staterna, 59501
- Northern Montana Hospital
-
Helena, Montana, Förenta staterna, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, Förenta staterna, 59801
- Community Medical Center
-
Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Förenta staterna, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Förenta staterna, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
North Carolina
-
Goldsboro, North Carolina, Förenta staterna, 27534
- Wayne Memorial Hospital, Incorporated
-
Hendersonville, North Carolina, Förenta staterna, 28791
- Pardee Memorial Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Förenta staterna, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Broadway
-
Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
-
Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Förenta staterna, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Förenta staterna, 45420
- CCOP - Dayton
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, Förenta staterna, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
-
Kettering, Ohio, Förenta staterna, 45429
- Charles F. Kettering Memorial Hospital
-
Troy, Ohio, Förenta staterna, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wilmington, Ohio, Förenta staterna, 45177
- Clinton Memorial Hospital
-
Wright-Patterson Afb, Ohio, Förenta staterna, 45433-5529
- United States Air Force Medical Center - Wright-Patterson
-
Xenia, Ohio, Förenta staterna, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Förenta staterna, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Milwaukie, Oregon, Förenta staterna, 97222
- Providence Milwaukie Hospital
-
Portland, Oregon, Förenta staterna, 97216
- Adventist Medical Center
-
Portland, Oregon, Förenta staterna, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Förenta staterna, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Förenta staterna, 97225
- Providence St. Vincent Medical Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Tennessee
-
Kingsport, Tennessee, Förenta staterna, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
-
Virginia
-
Danville, Virginia, Förenta staterna, 24541
- Danville Regional Medical Center
-
-
Washington
-
Vancouver, Washington, Förenta staterna, 98668
- Southwest Washington Medical Center Cancer Center
-
-
Wisconsin
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
-
Wyoming
-
Casper, Wyoming, Förenta staterna, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Mixed histology allowed if all components are consistent with NSCLC
- Squamous cell histology allowed
Stage IV disease
Oligometastatic disease (M1 with 1-3 metastases)
- Patients with M1 disease that involves intrapulmonary metastases are eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of radiotherapy
- 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
- Patients who have had up to 3 brain metastases allowed provided they have been treated with not signs of progression
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:
- Carcinoma in situ of the cervix
- Nonmelanoma skin cancer
- History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if diagnosed within the past 5 years
- Stage I breast cancer that was treated within the past 5 years
- Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no subsequent evidence of recurrence
No concurrent severe and/or uncontrolled medical condition, including any of the following:
- Angina pectoris
- Congestive heart failure within the past 3 months, unless LVEF > 40%
- Myocardial infarction within the past 6 months
- Cardiac arrhythmia
- No clinically significant infection
- No psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy for this cancer other than 2-6 courses of standard platinum-based chemotherapy with or without bevacizumab
- No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically involved nodes, or metastatic lesions)
- No bevacizumab during and for 4 weeks after completion of radiotherapy
- No concurrent systemic chemotherapy
- No other maintenance systemic therapy during radiotherapy
- No other concurrent investigational agents for the primary neoplasm
- No concurrent intensity modulated radiotherapy
- No concurrent prophylactic nodal radiotherapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Arm I
Patients undergo observation for 6 weeks.
|
Patients undergo observation for 6 weeks.
|
Experimentell: Arm II
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
|
Patients undergo radiotherapy 5 days a week for 6 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Survival
Tidsram: 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
|
Time from registration to death or last follow-up (up to 5 years)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Response Rate
Tidsram: 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.
|
Up to 5 years
|
Progression-free Survival
Tidsram: 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 from registration to disease progression or death (up to 5 years)
|
Time to Disease Progression
Tidsram: 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 from registration to disease progression (up to 5 years)
|
Time to Treatment Failure
Tidsram: 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.
|
Up to 5 years
|
Duration of Response
Tidsram: 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.
|
Up to 5 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Steven E. Schild, MD, Mayo Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCCTG-N0724
- NCI-2009-00664 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000616868 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Lungcancer
-
University of ZurichDeep Breath Intelligence (DBI)RekryteringLung-/luftvägssjukdomarSchweiz
-
424 General Military HospitalAvslutad
-
Chang Gung Memorial HospitalAvslutad
-
Celularity IncorporatedAvslutadSteg 2 Lung sarkoidos | Steg 3 Lung sarkoidosFörenta staterna
-
Centre Hospitalier Universitaire, AmiensAvslutadHemodialyskomplikation | Lung ultraljudFrankrike
-
Tuberculosis Research Centre, IndiaInternational Union Against Tuberculosis and Lung Diseases; Sarvodaya Charitable... och andra samarbetspartnersAktiv, inte rekryterandePre-extensivt läkemedelsresistent lung-TB | Behandling Intolerant multiresistent lung-TB | Icke-responsiv multiresistent lung-TBIndien
-
Pontificia Universidad Catolica de ChileRekryteringLung ultraljud | Öppen bukkirurgiChile
-
University of Colorado, DenverChildren's Hospital Colorado; Food and Drug Administration (FDA)AvslutadHypertoni;Lung;PrimärFörenta staterna
-
Papa Giovanni XXIII HospitalAvslutadLungtransplantation | Ex Vivo Lung PerfusionItalien
-
University Hospital, LilleAvslutad
Kliniska prövningar på clinical observation
-
Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine,...Okänd
-
Thomas Jefferson UniversityAvslutadHematopoetisk och lymfoid cellneoplasma | Malign fast neoplasmaFörenta staterna
-
BC Centre for Improved Cardiovascular HealthUniversity of British ColumbiaOkänd
-
University Hospital, GrenobleRekryteringHöftprotesinfektionFrankrike
-
Indiana UniversityAvslutad
-
University of MiamiRekrytering
-
Linkoeping UniversityAktiv, inte rekryterandeHjärtinfarkt | SvaghetSverige
-
University of SaskatchewanNovartis; Lung Association of SaskatchewanOkändLungsjukdom, kronisk obstruktivKanada
-
Anabela Correia MartinsSensing Future Technologies; Fraunhofer Portugal Research Center for Assistive...Okänd
-
Northwestern UniversityHar inte rekryterat ännuHjärtsvikt Med Minskad Ejection FraktionFörenta staterna