- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003158
S9712: Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III Non-small Cell Lung Cancer
A Phase II Trial of Concurrent Carboplatin/VP-16 and Radiation Followed by Paclitaxel (Taxol) for Poor-Risk Stage III Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy and chemotherapy consisting of carboplatin, etoposide and paclitaxel in treating patients with newly diagnosed stage III non-small cell lung cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES: I. Assess the survival and failure-free survival in poor risk patients with stage IIIA or IIIB non-small cell lung carcinoma treated with concurrent radiation, carboplatin, and etoposide followed by consolidation with paclitaxel. II. Evaluate the response and toxicities associated with this regimen in this group of poor risk patients.
OUTLINE: This is nonrandomized study. Chemotherapy on cycle 1 starts on day 1 with concurrent initiation of radiotherapy. Chemotherapy is given prior to radiotherapy on those days when both treatments are given. Cycle 2 begins on day 29. Carboplatin is administered by 15 minute IV infusions on days 1, 3, 29, and 31. Etoposide (VP-16) is administered after carboplatin by 30 minute IV infusions on days 1-4, and 29-32. Radiation therapy begins within 24 hours of day 1, cycle 1 of chemotherapy. The primary tumor, the adjacent mediastinum, and other targeted lymph nodes are administered radiotherapy daily 5 days a week for 6.5 weeks. After the 2 cycles of chemotherapy and chest radiotherapy, patients who have stable disease, partial response, or complete response receive 3 cycles of paclitaxel. Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of chemotherapy and radiotherapy and repeated every 3-4 weeks (approximately days 71, 92, and 103) for a total of 3 cycles. Patients are followed every month for the first year, every 3 months for the second year, every 6 months for the third year, and then annually thereafter while on treatment. After treatment, patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: There will be 80 patients accrued in this study over 16 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forenede Stater, 91010
- Beckman Research Institute, City of Hope
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Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forenede Stater, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Medical Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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San Francisco, California, Forenede Stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forenede Stater, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forenede Stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Springfield, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Forenede Stater, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, Forenede Stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Hospital - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Forenede Stater, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Forenede Stater, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Cancer Research & Treatment Center
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New York
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Brooklyn, New York, Forenede Stater, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forenede Stater, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, Forenede Stater, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Forenede Stater, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Forenede Stater, 78284
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed single primary bronchogenic non-small cell lung cancer (NSCLC) Stage IIIA (T1-2 N2 M0; T3 N0-2 M0) or IIIB (T4 or N3 M0, excluding malignant pleural effusion) Following NSCLC cellular types are eligible: adenocarcinoma large cell carcinoma squamous cell carcinoma unspecified Histology or cytology from involved mediastinal or supraclavicular nodes are sufficient for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on radiographs Radiographic evidence of mediastinal lymph nodes of at least 1.5 cm in the largest diameter is sufficient to stage N2 or N3 If the largest mediastinal nodes are less than 1.5 cm in diameter and this is the basis for stage III disease, then at least one of the nodes has to be proven positive cytologically or histologically No bronchioloalveolar carcinoma or stage IIIB tumor involving the superior sulcus Patients must meet at least one of the following conditions: - FEV1 less than 2 liters and predicted FEV1 of the contralateral lung no greater than 800 mL based on the quantitative split function testing - Creatinine clearance less than 50 mL/min - Significant clinical hearing loss and unwilling to accept the potential for worsening due to cisplatin - Controlled congestive heart failure that, in the opinion of the investigator, may become decompensated due to excessive hydration prior to cisplatin administration - SWOG performance status 2 and either albumin less than 0.85 times upper limit of normal or weight loss of greater than 10% due to tumor Measurable or evaluable disease Patients with pleural effusion are eligible only if: - pleural fluid must be a transudate with negative cytology if present before mediastinoscopy or exploratory thoracotomy - pleural fluid can be either transudate or exudate with negative cytology if present only after exploratory or staging thoracotomy but not before - in any case, pleural effusion is present only on CT scan but not on decubitus chest x-ray, and it is deemed too small to tap under either CT or ultrasound guidance
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal SGOT no greater than 1.5 times upper limit of normal Renal: Creatinine clearance at least 20 mL/min Cardiovascular: No unstable congestive heart failure No active angina No unstable cardiac arrhythmias Pulmonary: FEV1 at least 1.0 liter Also See Disease Characteristics Other: No uncontrolled peptic ulcer disease No active infection No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years Not pregnant or nursing Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation for lung cancer Surgery: No prior surgery for lung cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Davies AM, Chansky K, Lau DH, Leigh BR, Gaspar LE, Weiss GR, Wozniak AJ, Crowley JJ, Gandara DR; SWOG S9712. Phase II study of consolidation paclitaxel after concurrent chemoradiation in poor-risk stage III non-small-cell lung cancer: SWOG S9712. J Clin Oncol. 2006 Nov 20;24(33):5242-6. doi: 10.1200/JCO.2006.07.0268.
- Davies AM, Lau DH, Crowley J, et al.: Concurrent carboplatin/etoposide and radiation followed by paclitaxel consolidation for poor risk stage III non-small cell lung cancer: a Southwest Oncology Group (SWOG) phase II trial (S9712). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1191, 2002.
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
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Carboplatin
- Etoposid
- Paclitaxel
Andre undersøgelses-id-numre
- CDR0000065951
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S9712 (Anden identifikator: SWOG)
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Kliniske forsøg med Lungekræft
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Mansoura UniversityRekrutteringOne Lung VentilationEgypten
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Chinese Chronic Respiratory Disease Research NetworkRekruttering
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Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
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Seoul National University HospitalAfsluttet
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Seoul National University HospitalAfsluttet
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Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
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Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
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Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
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University Health Network, TorontoAktiv, ikke rekrutterende
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Papa Giovanni XXIII HospitalAfsluttetLungetransplantation | Ex Vivo Lung PerfusionItalien
Kliniske forsøg med carboplatin
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Eisai Inc.AfsluttetKræftForenede Stater, Østrig, Indien
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NHS Greater Glasgow and ClydeAfsluttetLivmoderhalskræft | Æggelederkræft | Primær peritoneal kræftDet Forenede Kongerige, Australien, New Zealand
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Duke UniversityAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada
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Samyang Biopharmaceuticals CorporationAfsluttet
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National Cancer Institute (NCI)Children's Oncology GroupAfsluttetTumorer i hjernen og centralnervesystemetForenede Stater, Canada, Puerto Rico, Australien, Holland, New Zealand, Schweiz
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All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUkendtIntraokulært retinoblastomIndien
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H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
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Eli Lilly and CompanyAfsluttetLungeneoplasmerForenede Stater
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National Cancer Institute (NCI)AfsluttetBrystkræft | LivmoderhalskræftForenede Stater
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Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCAfsluttetTestikulær kimcelletumorDet Forenede Kongerige, Canada, Norge, Holland, Sydafrika, Brasilien, Finland