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Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

1. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Lungekræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.

Secondary

Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
Determine whether fear of death predicts survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259-5499
    - Mayo Clinic Scottsdale
- Florida
  - Hollywood, Florida, Forenede Stater, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jacksonville, Florida, Forenede Stater, 32224
    - Mayo Clinic - Jacksonville
- Illinois
  - Aurora, Illinois, Forenede Stater, 60507
    - Rush-Copley Cancer Care Center
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Effingham, Illinois, Forenede Stater, 62401
    - St. Anthony's Memorial Hospital
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic, PC
  - Galesburg, Illinois, Forenede Stater, 61401
    - InterCommunity Cancer Center of Western Illinois
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Forenede Stater, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Forenede Stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forenede Stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Forenede Stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forenede Stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - St. Margaret's Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Valley Cancer Center
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Forenede Stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Michigan City, Indiana, Forenede Stater, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic, PC
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Cedar Rapids Oncology Associates
  - Des Moines, Iowa, Forenede Stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forenede Stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, Forenede Stater, 50307
    - Mercy Capitol Hospital
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forenede Stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Forenede Stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forenede Stater, 67214
    - Wesley Medical Center
  - Wichita, Kansas, Forenede Stater, 67203
    - Associates in Womens Health, PA - North Review
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Adrian, Michigan, Forenede Stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, Forenede Stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, Forenede Stater, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Jackson, Michigan, Forenede Stater, 49201
    - Foote Memorial Hospital
  - Lambertville, Michigan, Forenede Stater, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Lansing, Michigan, Forenede Stater, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, Forenede Stater, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, Forenede Stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Mercy Memorial Hospital - Monroe
  - Pontiac, Michigan, Forenede Stater, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, Forenede Stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, Forenede Stater, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Warren, Michigan, Forenede Stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Lichfield, Minnesota, Forenede Stater, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, Forenede Stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, Forenede Stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - Shakopee, Minnesota, Forenede Stater, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St Paul, Minnesota, Forenede Stater, 55102
    - HealthEast Cancer Care at St. Joseph's Hospital
  - St. Cloud, Minnesota, Forenede Stater, 56303
    - CentraCare Clinic - River Campus
  - St. Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Cancer Center
  - St. Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - St. Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
  - Woodbury, Minnesota, Forenede Stater, 55125
    - HealthEast Cancer Care at Woodwinds Health Campus
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forenede Stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forenede Stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forenede Stater, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Forenede Stater, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, Forenede Stater, 59107-5100
    - Billings Clinic Cancer Center
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forenede Stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forenede Stater, 59405
  - Great Falls, Montana, Forenede Stater, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forenede Stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Forenede Stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forenede Stater, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Forenede Stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forenede Stater, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, Forenede Stater, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, Forenede Stater, 68131-2197
    - Creighton University Medical Center
- North Carolina
  - Rutherfordton, North Carolina, Forenede Stater, 28139
    - Rutherford Hospital
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forenede Stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Grand Forks, North Dakota, Forenede Stater, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Bowling Green, Ohio, Forenede Stater, 43402
    - Wood County Oncology Center
  - Dayton, Ohio, Forenede Stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forenede Stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forenede Stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Findlay, Ohio, Forenede Stater, 45840
    - Blanchard Valley Medical Associates
  - Fremont, Ohio, Forenede Stater, 43420
    - Fremont Memorial Hospital
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, Forenede Stater, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Forenede Stater, 43537
    - St. Luke's Hospital
  - Middletown, Ohio, Forenede Stater, 45044
    - Middletown Regional Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forenede Stater, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Coast Cancer Care, Incorporated
  - Sylvania, Ohio, Forenede Stater, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Forenede Stater, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forenede Stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forenede Stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forenede Stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Forenede Stater, 43567
    - Fulton County Health Center
  - Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, Forenede Stater, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - State College, Pennsylvania, Forenede Stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - AnMed Cancer Center
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Forenede Stater, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, Forenede Stater, 22401
    - Fredericksburg Oncology, Incorporated
- Wisconsin
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Franciscan Skemp Healthcare - La Crosse Campus
- Wyoming
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA or IIIB disease
Must be a candidate for curative radiotherapy
Not a candidate for other concurrent chemotherapy and radiotherapy
No surgical treatment available
No pleural effusion suspected or proven to be malignant
No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days

PATIENT CHARACTERISTICS:

Age * 18 and over

Performance status

Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
ECOG 2 (age 18 to 64 years)

Life expectancy

* At least 12 weeks

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
AST ≤ 3 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Pulmonary

FEV_1 ≥ 1 L
No idiopathic pulmonary fibrosis

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Magnesium normal
No uncontrolled infection
No other severe underlying disease that would preclude study entry
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
No major psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

See Disease Characteristics
No prior chemotherapy for NSCLC

Endocrine therapy

* Not specified

Radiotherapy

No prior therapeutic radiotherapy to the chest
No concurrent intensity modulated radiotherapy

Other

* No prior epidermal growth factor receptor inhibitors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: cetuximab/Radiation Cetuximab (C225) and Radiation	Stråling: strålebehandling Biologisk: cetuximab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
11-month Survival Rate Tidsramme: From baseline to 11 months.	Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.	From baseline to 11 months.

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Survival Time Tidsramme: From baseline to up to 3 years	Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.	From baseline to up to 3 years
Time to Disease Progression Tidsramme: From Baseline to up to 3 years	Time to disease progression is defined as the time from registration to documentation of disease progression. 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.	From Baseline to up to 3 years
Tumor Response (Complete and Partial) Tidsramme: Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration	A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.	Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Jatoi A, Schild SE, Foster N, Henning GT, Dornfeld KJ, Flynn PJ, Fitch TR, Dakhil SR, Rowland KM, Stella PJ, Soori GS, Adjei AA. A phase II study of cetuximab and radiation in elderly and/or poor performance status patients with locally advanced non-small-cell lung cancer (N0422). Ann Oncol. 2010 Oct;21(10):2040-2044. doi: 10.1093/annonc/mdq075. Epub 2010 Jun 21.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. februar 2008

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

26. juli 2005

Først indsendt, der opfyldte QC-kriterier

26. juli 2005

Først opslået (Skøn)

28. juli 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCCTG-N0422
NCI-2012-02664 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000435991 (Registry Identifier: PDQ (Physician Data Query))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Mansoura University

Rekruttering

Sammenligning af tre metoder til PEEP-titrering under én lungeventilation i liggende stilling

One Lung Ventilation

Egypten
Chinese Chronic Respiratory Disease Research Network

Rekruttering

Kohorteundersøgelse af lungeknudeintervention (LNICS)

Hændelse Lung Nodule

Kina
Dokuz Eylul University

Afsluttet

Evaluering af en lungeventilation med ultralyd ved thoraxkirurgiske operationer

One Lung Ventilation

Kalkun
Seoul National University Hospital

Afsluttet

Effektiviteten af Lung Sono i One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Seoul National University Hospital

Afsluttet

Forkonditionering af One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Yonsei University

Afsluttet

Positivt endeekspiratorisk tryk og alveolær rekruttering til én lungeventilation

One Lung Ventilation

Korea, Republikken
Sichuan University
West China Hospital

Midlertidigt ikke tilgængelig

Ændringen af pulmonal blodgennemstrømning under én lungeventilation

One Lung Ventilation
Joseph D. Tobias

Afsluttet

Intracuff-tryk under en-lungeventilation hos spædbørn og børn

One-lung Ventilation (OLV)

Forenede Stater
University Health Network, Toronto

Aktiv, ikke rekrutterende

TorEx lungeperfusionssystem

Lungetransplantation | Ex Vivo Lung Perfusion

Canada
Papa Giovanni XXIII Hospital

Afsluttet

Ex Vivo Lungeperfusion i Bergamo Lungetransplantationsprogram

Lungetransplantation | Ex Vivo Lung Perfusion

Italien

Kliniske forsøg med strålebehandling

Alpha Tau Medical LTD.

Rekruttering

Alfastrålingsudsenderanordning til behandling af tilbagevendende lungekræft

Lungekræft | Tilbagevendende lungekræft

Israel
Alpha Tau Medical LTD.

Rekruttering

Alpha Radiation Emitters Device (DaRT) til behandling af kutan, slimhinde eller overfladisk blødt vævsneoplasi.

Hudkræft | Slimhinde-neoplasma i mundhulen | Neoplasma af blødt væv

Israel
Alpha Tau Medical LTD.

Rekruttering

Neoadjuverende interstitiel brachyterapi med diffuserende alfa-emittere strålebehandling hos mænd med prostatakræft

Prostata Adenocarcinom

Israel
Medical College of Wisconsin

Aktiv, ikke rekrutterende

Højdosis lymfeknudeintensitetsmoduleret strålebehandling og hypofraktioneret prostata (SIB) (SIB)

Prostatakræft

Forenede Stater
Alpha Tau Medical LTD.

Rekruttering

Alpha Radiation Emitters Device (DaRT) til behandling af kutan, slimhinde eller overfladisk blødt vævsneoplasi

Hudkræft | Slimhinde-neoplasma i mundhulen | Neoplasma af blødt væv

Israel
Alpha Tau Medical LTD.

Afsluttet

Alfastrålingsudsenderanordning til behandling af nydiagnosticerede brystkarcinompatienter med fjernmetastaser

Metastatisk brystkræft | Brystkarcinom | Invasiv brystkræft | Fjernmetastaser.Patologi

Den Russiske Føderation
Alpha Tau Medical LTD.

Afsluttet

Alfastrålingsudsenderanordning til behandling af planocellulært karcinom (DaRT)

Planocellulært hudkræft

Italien
Alpha Tau Medical LTD.
European Organisation for Research and Treatment of Cancer - EORTC

Ikke rekrutterer endnu

Neoadjuvant DaRT til Locally Advanced Oral Cavity SCC

Planocellulært karcinom i hoved og hals | Planocellulært karcinom

Israel
Alpha Tau Medical LTD.

Rekruttering

Alfa-strålingsudsenderanordning til behandling af kutan, slimhinde og overfladisk blødtvævsneoplasi (DaRT)

Hudkræft | Slimhinde-neoplasma i mundhulen | Neoplasma af blødt væv

Italien
Alpha Tau Medical LTD.

Aktiv, ikke rekrutterende

Alfastrålingsudsenderanordning til behandling af kutan, slimhinde eller overfladisk blødtvævsneoplasi (DaRT)

Hudkræft | Slimhinde-neoplasma i mundhulen | Neoplasma af blødt væv

Israel

Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Lungekræft

Kliniske forsøg med strålebehandling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bahrain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer