- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478699
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (GECP-SCAT)
July 3, 2015 updated by: Spanish Lung Cancer Group
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
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alicante, Spain, 03010
- H.G.U. Alicante
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Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spain, 08025
- Hospital de La Santa Creu I Sant Pau
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Barcelona, Spain, 08036
- Hospital Univ. Sagrat Cor
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Barcelona, Spain, 28036
- Instituto Universitario Dexeus
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Castellón, Spain
- Hospital Provincial de Castellón
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Córdoba, Spain, 14004
- Hospital Reina Sofia
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Girona, Spain, 17007
- Ico-Girona (Hospital Josep Trueta)
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Granada, Spain, 18015
- Hospital Virgen de las Nieves
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Jaén, Spain, 23007
- Hospital de Jaen
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Leon, Spain
- Hospital de Leon
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Lleida, Spain, 46015
- Hospital Arnau de Vilanova
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz
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Madrid, Spain, 28046
- Hospital La Paz
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Madrid, Spain, 28006
- Hospital de La Princesa
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Madrid, Spain, 28222
- Hospital Puerta de Hierro
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Madrid, Spain, 28006
- Hospital 12 de Octubre
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Madrid, Spain, 28006
- Hospital Clinico San Carlos
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Madrid, Spain, 28033
- Md Anderson Internacional
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Malaga, Spain, 29010
- Hospital Carlos Haya
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Murcia, Spain, 30008
- Hospital Morales Messeguer
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Palma de Mallorca, Spain, 07198
- Hospital Son Llatzer
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Palma de Mallorca, Spain, 07012
- Clinica Rotger
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Palma de Mallorca, Spain, 07014
- Hospital Son Dureta
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Salamanca, Spain, 37007
- Hospital Clinico De Salamanca
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San Sebastián, Spain, 20014
- Hospital de Donostia
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San Sebastián, Spain
- Instituto Oncológico de San Sebastián
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Santa Cruz de Tenerife, Spain
- Hospital Universitario de Canarias
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Valencia, Spain
- Instituto Valenciano de Oncologia
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Valencia, Spain
- Hospital General de Valencia
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Valencia, Spain, 46015
- H. Arnau de Vilanova
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Zamora, Spain, 49012
- Hospital Provincial de Zamora
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Zaragoza, Spain
- Hospital Lozano Blesa
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Zaragoza, Spain
- Hospital Miguel Servet
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Alicante
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Elche, Alicante, Spain, 03202
- Hospital de Elche
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Asturias
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Oviedo, Asturias, Spain
- Hospital Central de Asturias
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Barcelona
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Badalona, Barcelona, Spain, 08916
- ICO - H. Germans Trias i Pujol
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Manresa, Barcelona, Spain, 08243
- Hospital D'Althaia
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Mataró, Barcelona, Spain, 08034
- Hospital de Mataro
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, Spain
- Hospital Insular de Gran Canaria
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La Coruna
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Santiago de Compostela, La Coruna, Spain, 15076
- Hospital Clin. Univ. Santiago de Compostela
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La Rioja
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Logrono, La Rioja, Spain, 26004
- Hospital San Pedro
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Madrid
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Alcorcon, Madrid, Spain, 28922
- F.H.Alcorcón
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Leganés, Madrid, Spain, 28911
- Hospital Severo Ochoa
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Valencia
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Alzira, Valencia, Spain, 46600
- Hospital de La Ribera
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Vizcaya
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Baracaldo, Vizcaya, Spain, 48903
- Hospital de Cruces
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Bilbao, Vizcaya, Spain
- Hospital de Basurto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
|
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
|
EXPERIMENTAL: 2
|
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Docetaxel 75 mg/m2 day 1, 4 cycles
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate overall survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Bartomeu Massutí Sureda, MD, Hospital General Universitario de Alicante
- Study Chair: Jose Miguel Sanchez Torres, MD, Hospital de La Princesa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
May 24, 2007
First Submitted That Met QC Criteria
May 24, 2007
First Posted (ESTIMATE)
May 25, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 3, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
- Cisplatin
Other Study ID Numbers
- GECP-SCAT
- EudraCT Code: 2007-000067-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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