Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (GECP-SCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478699
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : July 7, 2015
Information provided by (Responsible Party):
Spanish Lung Cancer Group

Brief Summary:
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Docetaxel/Cisplatin Drug: Docetaxel Drug: Gemcitabine/Cisplatin Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Evaluate overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478699

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
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
Study Chair: Bartomeu Massutí Sureda, MD Hospital General Universitario de Alicante
Study Chair: Jose Miguel Sanchez Torres, MD HOSPITAL DE LA PRINCESA

Additional Information:
Responsible Party: Spanish Lung Cancer Group Identifier: NCT00478699     History of Changes
Other Study ID Numbers: GECP-SCAT
EudraCT Code: 2007-000067-15
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Spanish Lung Cancer Group:
BRCA1 mRNA Levels

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
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