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 |
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 | |
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: | | | 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 |
