Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA in Non-Small Cell Lung Cancer - Full Text View

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 by Spanish Lung Cancer Group, February 2009

First Received: May 24, 2007 Last Updated: February 16, 2009 History of Changes

Sponsored by:	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

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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	Drug: Docetaxel/Cisplatin Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
2: Experimental	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 50 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	HOSPITAL 12 DE OCTUBRE

More Information

Additional Information:

Spanish Lung Cancer Group website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Spanish Lung Cancer Group ( Rafael Rosell )
Study ID Numbers:	GECP-SCAT, EudraCT Code: 2007-000067-15
Study First Received:	May 24, 2007
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00478699 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:

SCAT
BRCA1
BRCA1 mRNA Levels

ADJUVANT
LUNG
GECP-SCAT

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Immunologic Factors
Adjuvants, Immunologic
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Docetaxel
Respiratory Tract Diseases

Cisplatin
Radiation-Sensitizing Agents
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009