Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Spanish Lung Cancer Group.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: Eva Pereira +34 93 430 20 06 epereira@gecp.org

  Hide Study Locations
Locations
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 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 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 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         
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Principal Investigator: Manuel Dómine, MD         
Hospital de La Princesa Recruiting
Madrid, Spain, 28006
Principal Investigator: Ulpiano Jimenez, MD         
Hospital La Paz Recruiting
Madrid, Spain, 28046
Principal Investigator: Javier de Castro, MD         
Md Anderson Internacional Recruiting
Madrid, Spain, 28033
Principal Investigator: José Miguel Sánchez Torres, MD         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28006
Principal Investigator: José Luis González Larriba, MD         
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28006
Principal Investigator: Lara Iglesias, MD         
Hospital Puerta de Hierro Recruiting
Madrid, Spain, 28222
Principal Investigator: Mariano Provencio, 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         
Instituto Oncológico de San Sebastián Recruiting
San Sebastián, Spain
Principal Investigator: Jesús Alfaro, MD         
Hospital de Donostia Recruiting
San Sebastián, Spain, 20014
Principal Investigator: Alfredo Paredes, 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
H. Arnau de Vilanova Recruiting
Valencia, Spain, 46015
Principal Investigator: Vicente Alberola, MD         
Hospital General de Valencia Recruiting
Valencia, Spain
Principal Investigator: Carlos Camps, MD         
Instituto Valenciano de Oncología Recruiting
Valencia, Spain
Principal Investigator: Miguel Angel Muñoz, MD         
Hospital Provincial de Zamora Recruiting
Zamora, Spain, 49012
Principal Investigator: Teresa de Portugal, MD         
Hospital Lozano Blesa Recruiting
Zaragoza, Spain
Principal Investigator: Dolores Isla, MD         
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Principal Investigator: Angel Artal, 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:
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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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 October 01, 2014