- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36688
- MBCCOP - University of South Alabama
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Arizona
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Phoenix, Arizona, États-Unis, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, États-Unis, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, États-Unis, 85724
- Arizona Cancer Center
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Tucson, Arizona, États-Unis, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, États-Unis, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, États-Unis, 91010
- Beckman Research Institute, City of Hope
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Long Beach, California, États-Unis, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, États-Unis, 90033-0800
- USC/Norris Comprehensive Cancer Center
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Los Angeles, California, États-Unis, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Oakland, California, États-Unis, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, États-Unis, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Medical Center
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Sacramento, California, États-Unis, 95817
- University of California Davis Cancer Center
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San Francisco, California, États-Unis, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, États-Unis, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, États-Unis, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, États-Unis, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, États-Unis, 80262
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, États-Unis, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, États-Unis, 96813
- Cancer Research Center of Hawaii
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Illinois
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Hines, Illinois, États-Unis, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, États-Unis, 60153
- Loyola University Medical Center
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Springfield, Illinois, États-Unis, 62526
- CCOP - Central Illinois
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Kansas
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Kansas City, Kansas, États-Unis, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, États-Unis, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, États-Unis, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, États-Unis, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, États-Unis, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, États-Unis, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, États-Unis, 71130
- Veterans Affairs Medical Center - Shreveport
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Shreveport, Louisiana, États-Unis, 71130-3932
- Louisiana State University Hospital - Shreveport
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, États-Unis, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, États-Unis, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Detroit, Michigan, États-Unis, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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Detroit, Michigan, États-Unis, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, États-Unis, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, États-Unis, 48075-9975
- Providence Hospital - Southfield
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Mississippi
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Biloxi, Mississippi, États-Unis, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, États-Unis, 39216-4505
- University Of Mississippi Medical Center
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Jackson, Mississippi, États-Unis, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, États-Unis, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, États-Unis, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, États-Unis, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, États-Unis, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, États-Unis, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, États-Unis, 87131
- University of New Mexico Cancer Research & Treatment Center
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New York
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Brooklyn, New York, États-Unis, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, États-Unis, 10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, États-Unis, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Cancer Center
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Columbus, Ohio, États-Unis, 43206
- CCOP - Columbus
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Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, États-Unis, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, États-Unis, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, États-Unis, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Portland, Oregon, États-Unis, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, États-Unis, 97213
- CCOP - Columbia River Program
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South Carolina
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Greenville, South Carolina, États-Unis, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, États-Unis, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, États-Unis, 78234
- Brooke Army Medical Center
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Galveston, Texas, États-Unis, 77555-1329
- University of Texas Medical Branch
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Lubbock, Texas, États-Unis, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, États-Unis, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, États-Unis, 78284
- University of Texas Health Science Center at San Antonio
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Temple, Texas, États-Unis, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, États-Unis, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- Huntsman Cancer Institute
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Salt Lake City, Utah, États-Unis, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Washington
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Seattle, Washington, États-Unis, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, États-Unis, 98104
- Swedish Cancer Institute
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Seattle, Washington, États-Unis, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, États-Unis, 98405-0986
- CCOP - Northwest
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Carboplatine
- Étoposide
- Paclitaxel
Autres numéros d'identification d'étude
- CDR0000065951
- U10CA032102 (Subvention/contrat des NIH des États-Unis)
- S9712 (Autre identifiant: SWOG)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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