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Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (GECP-SCAT)
This study has been completed.
Sponsor:
Spanish Lung Cancer Group
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00478699
First received: May 24, 2007
Last updated: July 3, 2015
Last verified: July 2015
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Purpose
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
| Condition | Intervention | Phase |
|---|---|---|
| Non-small-cell Lung Cancer | Drug: Docetaxel/Cisplatin Drug: Docetaxel Drug: Gemcitabine/Cisplatin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Spanish Lung Cancer Group:
Primary Outcome Measures:
- Evaluate overall survival [ Time Frame: 5 years ]
Secondary Outcome Measures:
- Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment. [ Time Frame: 5 years ]
| Enrollment: | 500 |
| Study Start Date: | June 2007 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
|
| Experimental: 2 |
Drug: Docetaxel
Docetaxel 75 mg/m2 day 1, 4 cycles
Drug: Gemcitabine/Cisplatin
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
|
Detailed Description:
Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histological confirmation of non-small-cell lung carcinoma.
- Complete surgical resection of the disease.
- Tumoral tissue available for molecular analysis.
- N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
- Men or women age 18 years or older.
- Patients with a performance status of 2 or less according to the ECOG classification.
- Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
- Complete recovery from surgery within 6 weeks.
- Patients who have given written informed consent before initiating any specific study screening procedure.
Exclusion Criteria:
- Patients who have received previously chemotherapy or radiotherapy for the study disease.
- Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
- Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
- Women who are pregnant or in the period of lactation.
- Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
- Patients under treatment with investigational agents.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478699
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478699
Locations
| Spain | |
| Hospital de Elche | |
| Elche, Alicante, Spain, 03202 | |
| Hospital Central de Asturias | |
| Oviedo, Asturias, Spain | |
| Ico - H. Germans Trias I Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital D'Althaia | |
| Manresa, Barcelona, Spain, 08243 | |
| Hospital de Mataró | |
| Mataró, Barcelona, Spain, 08034 | |
| Hospital Insular de Gran Canaria | |
| Las Palmas de Gran Canaria, Gran Canaria, Spain | |
| Hospital Clin. Univ. Santiago de Compostela | |
| Santiago de Compostela, La Coruna, Spain, 15076 | |
| Hospital San Pedro | |
| Logrono, La Rioja, Spain, 26004 | |
| F.H.Alcorcon | |
| Alcorcon, Madrid, Spain, 28922 | |
| Hospital Severo Ochoa | |
| Leganés, Madrid, Spain, 28911 | |
| Hospital de La Ribera | |
| Alzira, Valencia, Spain, 46600 | |
| Hospital de Cruces | |
| Baracaldo, Vizcaya, Spain, 48903 | |
| Hospital de Basurto | |
| Bilbao, Vizcaya, Spain | |
| H.G.U. Alicante | |
| Alicante, Spain, 03010 | |
| Hospital de La Santa Creu I Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Clínic de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Univ. Sagrat Cor | |
| Barcelona, Spain, 08036 | |
| Instituto Universitario Dexeus | |
| Barcelona, Spain, 28036 | |
| Hospital Provincial de Castellón | |
| Castellón, Spain | |
| Hospital Reina Sofía | |
| Córdoba, Spain, 14004 | |
| Ico-Girona (Hospital Josep Trueta) | |
| Girona, Spain, 17007 | |
| Hospital Virgen de Las Nieves | |
| Granada, Spain, 18015 | |
| Hospital de Jaén | |
| Jaén, Spain, 23007 | |
| Hospital de León | |
| Leon, Spain | |
| Hospital Arnau de Vilanova | |
| Lleida, Spain, 46015 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28006 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28006 | |
| Hospital de La Princesa | |
| Madrid, Spain, 28006 | |
| Md Anderson Internacional | |
| Madrid, Spain, 28033 | |
| Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Puerta de Hierro | |
| Madrid, Spain, 28222 | |
| Hospital Carlos Haya | |
| Malaga, Spain, 29010 | |
| Hospital Morales Messeguer | |
| Murcia, Spain, 30008 | |
| Clínica Rotger | |
| Palma de Mallorca, Spain, 07012 | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain, 07014 | |
| Hospital Son Llátzer | |
| Palma de Mallorca, Spain, 07198 | |
| Hospital Clinico de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital de Donostia | |
| San Sebastián, Spain, 20014 | |
| Instituto Oncológico de San Sebastián | |
| San Sebastián, Spain | |
| Hospital Universitario de Canarias | |
| Santa Cruz de Tenerife, Spain | |
| H. Arnau de Vilanova | |
| Valencia, Spain, 46015 | |
| Hospital General de Valencia | |
| Valencia, Spain | |
| Instituto Valenciano de Oncología | |
| Valencia, Spain | |
| Hospital Provincial de Zamora | |
| Zamora, Spain, 49012 | |
| Hospital Lozano Blesa | |
| Zaragoza, Spain | |
| Hospital Miguel Servet | |
| Zaragoza, Spain | |
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
| Study Chair: | Bartomeu Massutí Sureda, MD | Hospital General Universitario de Alicante |
| Study Chair: | Jose Miguel Sanchez Torres, MD | HOSPITAL DE LA PRINCESA |
More Information
Additional Information:
| Responsible Party: | Spanish Lung Cancer Group |
| ClinicalTrials.gov Identifier: | NCT00478699 History of Changes |
| Other Study ID Numbers: |
GECP-SCAT EudraCT Code: 2007-000067-15 |
| Study First Received: | May 24, 2007 |
| Last Updated: | July 3, 2015 |
Keywords provided by Spanish Lung Cancer Group:
|
SCAT BRCA1 BRCA1 mRNA Levels |
ADJUVANT LUNG GECP-SCAT |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Docetaxel Cisplatin |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on July 17, 2017