- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Mobile, Alabama, Förenta staterna, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, Förenta staterna, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Förenta staterna, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Förenta staterna, 85724
- Arizona Cancer Center
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Tucson, Arizona, Förenta staterna, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Förenta staterna, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Förenta staterna, 91010
- Beckman Research Institute, City of Hope
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Long Beach, California, Förenta staterna, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Förenta staterna, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, Förenta staterna, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, Förenta staterna, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Förenta staterna, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Medical Center
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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San Francisco, California, Förenta staterna, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Förenta staterna, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Förenta staterna, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Förenta staterna, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Förenta staterna, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Förenta staterna, 96813
- Cancer Research Center of Hawaii
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Illinois
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Hines, Illinois, Förenta staterna, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Springfield, Illinois, Förenta staterna, 62526
- CCOP - Central Illinois
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Förenta staterna, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Förenta staterna, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, Förenta staterna, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, Förenta staterna, 71130
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, Förenta staterna, 71130-3932
- Louisiana State University Hospital - Shreveport
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Förenta staterna, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, Förenta staterna, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
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Detroit, Michigan, Förenta staterna, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Förenta staterna, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Förenta staterna, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, Förenta staterna, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Förenta staterna, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Förenta staterna, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Förenta staterna, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Förenta staterna, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Förenta staterna, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Förenta staterna, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Förenta staterna, 87131
- University of New Mexico Cancer Research & Treatment Center
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New York
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Brooklyn, New York, Förenta staterna, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, Förenta staterna, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Cancer Center
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Columbus, Ohio, Förenta staterna, 43206
- CCOP - Columbus
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Dayton, Ohio, Förenta staterna, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Förenta staterna, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, Förenta staterna, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Förenta staterna, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Förenta staterna, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Förenta staterna, 78234
- Brooke Army Medical Center
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Galveston, Texas, Förenta staterna, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, Förenta staterna, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, Förenta staterna, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, Förenta staterna, 78284
- University of Texas Health Science Center at San Antonio
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Temple, Texas, Förenta staterna, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Förenta staterna, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Förenta staterna, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, Förenta staterna, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, Förenta staterna, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Förenta staterna, 98104
- Swedish Cancer Institute
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Seattle, Washington, Förenta staterna, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Förenta staterna, 98405-0986
- CCOP - Northwest
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna 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.
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 (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Karboplatin
- Etoposid
- Paklitaxel
Andra studie-ID-nummer
- CDR0000065951
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- S9712 (Annan identifierare: SWOG)
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