Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
This study is currently recruiting participants.
Verified March 2012 by Spanish Lung Cancer Group
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: December 13, 2012
Last verified: March 2012
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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 Endpoint Classification: Safety/Efficacy Study 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:
Further study details as provided by Spanish Lung Cancer Group:
Primary Outcome Measures:
- Evaluate overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 432 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478699
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Contacts
| Contact: Eva Pereira | +34 93 430 20 06 | epereira@gecp.org |
Hide Study LocationsLocations
| Spain | |
| Hospital Virgen de Los Lirios | Withdrawn |
| Alcoi, Alicante, Spain, 03801 | |
| Hospital de Elche | Recruiting |
| Elche, Alicante, Spain, 03202 | |
| Principal Investigator: Natividad Martínez, MD | |
| Hospital Central de Asturias | Recruiting |
| Oviedo, Asturias, Spain | |
| Principal Investigator: Emilio Esteban, MD | |
| Ico - H. Germans Trias I Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Rafael Rosell, MD 934978925 | |
| Principal Investigator: Rafael Rosell, MD | |
| Hospital D'Althaia | Recruiting |
| Manresa, Barcelona, Spain, 08243 | |
| Principal Investigator: Silvia Catot, MD | |
| Hospital de Mataró | Recruiting |
| Mataró, Barcelona, Spain, 08034 | |
| Principal Investigator: Pilar Lianes, MD | |
| Hospital Insular de Gran Canaria | Recruiting |
| Las Palmas de Gran Canaria, Gran Canaria, Spain | |
| Principal Investigator: Adolfo Murias, MD | |
| Hospital Clin. Univ. Santiago de Compostela | Recruiting |
| Santiago de Compostela, La Coruna, Spain, 15076 | |
| Principal Investigator: Francisca Vazquez, MD | |
| Hospital San Pedro | Recruiting |
| Logrono, La Rioja, Spain, 26004 | |
| Principal Investigator: Isabel Manrique, MD | |
| F.H.Alcorcon | Recruiting |
| Alcorcon, Madrid, Spain, 28922 | |
| Contact: Susana Hernando, MD 916219744 | |
| Principal Investigator: Susana Hernando, MD | |
| Hospital Severo Ochoa | Recruiting |
| Leganés, Madrid, Spain, 28911 | |
| Principal Investigator: Ana López, MD | |
| Hospital de La Ribera | Recruiting |
| Alzira, Valencia, Spain, 46600 | |
| Principal Investigator: Cristobal Gaspar, MD | |
| Hospital de Cruces | Recruiting |
| Baracaldo, Vizcaya, Spain, 48903 | |
| Principal Investigator: Guillermo Lopez Vivanco, MD | |
| Hospital de Basurto | Recruiting |
| Bilbao, Vizcaya, Spain | |
| Principal Investigator: Mª Angeles Sala, MD | |
| H.G.U. Alicante | Recruiting |
| Alicante, Spain, 03010 | |
| Contact: Bartomeu Massuti, MD 965938448 | |
| Principal Investigator: Bartomeu Massuti, MD | |
| Hospital Univ. Sagrat Cor | Recruiting |
| Barcelona, Spain, 08036 | |
| Principal Investigator: Ignacio Machegns, MD | |
| Instituto Universitario Dexeus | Recruiting |
| Barcelona, Spain, 28036 | |
| Principal Investigator: Santiago Viteri, MD | |
| Hospital Clínic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Principal Investigator: Nuria Viñolas, MD | |
| Hospital de La Santa Creu I Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Principal Investigator: Margarita Majem, MD | |
| Hospital General Yagüe | Withdrawn |
| Burgos, Spain, 09005 | |
| Hospital Provincial de Castellón | Recruiting |
| Castellón, Spain | |
| Principal Investigator: Ramón de las Peñas, MD | |
| Hospital Reina Sofía | Recruiting |
| Córdoba, Spain, 14004 | |
| Principal Investigator: Isidoro Barneto, MD | |
| Ico-Girona (Hospital Josep Trueta) | Recruiting |
| Girona, Spain, 17007 | |
| Principal Investigator: Rut Porta, MD | |
| Hospital Virgen de Las Nieves | Recruiting |
| Granada, Spain, 18015 | |
| Principal Investigator: Javier Valdivia, MD | |
| Hospital de Jaén | Recruiting |
| Jaén, Spain, 23007 | |
| Principal Investigator: Miguel Ángel Moreno, MD | |
| Hospital de León | Recruiting |
| Leon, Spain | |
| Principal Investigator: Pilar Diz, MD | |
| Hospital Arnau de Vilanova | Recruiting |
| Lleida, Spain, 46015 | |
| Principal Investigator: Diego Márquez, MD | |
| Hospital Puerta de Hierro | Recruiting |
| Madrid, Spain, 28222 | |
| Principal Investigator: Mariano Provencio, MD | |
| Hospital de La Princesa | Recruiting |
| Madrid, Spain, 28006 | |
| Principal Investigator: Ulpiano Jimenez, MD | |
| Hospital Clínico San Carlos | Recruiting |
| Madrid, Spain, 28006 | |
| Principal Investigator: José Luis González Larriba, MD | |
| Md Anderson Internacional | Recruiting |
| Madrid, Spain, 28033 | |
| Principal Investigator: José Miguel Sánchez Torres, MD | |
| Hospital La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Principal Investigator: Javier de Castro, MD | |
| Hospital 12 de Octubre | Recruiting |
| Madrid, Spain, 28006 | |
| Principal Investigator: Lara Iglesias, MD | |
| Fundación Jiménez Díaz | Recruiting |
| Madrid, Spain, 28040 | |
| Principal Investigator: Manuel Dómine, MD | |
| Hospital Carlos Haya | Recruiting |
| Malaga, Spain, 29010 | |
| Principal Investigator: Manuel Cobo Dols, MD | |
| Hospital Morales Messeguer | Recruiting |
| Murcia, Spain, 30008 | |
| Principal Investigator: Juan Antonio Macías, MD | |
| Clínica Rotger | Recruiting |
| Palma de Mallorca, Spain, 07012 | |
| Principal Investigator: Christian Rolfo, MD | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Spain, 07014 | |
| Principal Investigator: Josefa Terrassa, MD | |
| Hospital Son Llátzer | Recruiting |
| Palma de Mallorca, Spain, 07198 | |
| Principal Investigator: Isabel Bover, MD | |
| Hospital Clinico de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Principal Investigator: German Martin, MD | |
| Hospital de Donostia | Recruiting |
| San Sebastián, Spain, 20014 | |
| Principal Investigator: Alfredo Paredes, MD | |
| Instituto Oncológico de San Sebastián | Recruiting |
| San Sebastián, Spain | |
| Principal Investigator: Jesús Alfaro, MD | |
| Hospital Universitario de Canarias | Recruiting |
| Santa Cruz de Tenerife, Spain | |
| Principal Investigator: Juana Oramas, MD | |
| Hospital Ntra Sra de Valme | Withdrawn |
| Sevilla, Spain | |
| Hospital General de Soria | Withdrawn |
| Soria, Spain, 42005 | |
| Instituto Valenciano de Oncología | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Miguel Angel Muñoz, MD | |
| Hospital General de Valencia | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Carlos Camps, MD | |
| H. Arnau de Vilanova | Recruiting |
| Valencia, Spain, 46015 | |
| Principal Investigator: Vicente Alberola, MD | |
| Hospital Provincial de Zamora | Recruiting |
| Zamora, Spain, 49012 | |
| Principal Investigator: Teresa de Portugal, MD | |
| Hospital Miguel Servet | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Angel Artal, MD | |
| Hospital Lozano Blesa | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Dolores Isla, MD | |
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:
No publications provided
| 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: | December 13, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Spanish Lung Cancer Group:
|
SCAT BRCA1 BRCA1 mRNA Levels |
ADJUVANT LUNG GECP-SCAT |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adjuvants, Immunologic Gemcitabine Docetaxel Cisplatin |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013