GECP-SCAT：西班牙多西他赛选择性辅助化疗研究

GECP-SCAT-西班牙多西他赛选择性辅助化疗研究

Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA in Non-Small Cell Lung Cancer (GECP-SCAT)
This study is currently recruiting participants.
Verified on June 2011 by Spanish Lung Cancer Group

First Received on May 24, 2007.   Last Updated on June 20, 2011   History of Changes

Sponsor:	Spanish Lung Cancer Group
Information provided by:	Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:	NCT00478699

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 III

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:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Gemcitabine Docetaxel Gemcitabine hydrochloride
U.S. FDA Resources


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:	June 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intervention: Drug: Docetaxel/Cisplatin	Drug: Docetaxel/Cisplatin Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
2: Experimental Interventions: Drug: Docetaxel Drug: Gemcitabine/Cisplatin Drug: Docetaxel/Cisplatin	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

Contacts

Contact: Eva Pereira

+34 93 430 20 06

epereira@gecp.org

  Show 51 Study Locations
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	MD ANDERSON INTERNACIONAL

  More Information
Additional Information: Spanish Lung Cancer Group website  

No publications provided

Responsible Party:	Rafael Rosell, 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:	June 20, 2011
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 September 12, 2011

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