Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
This study is currently recruiting participants.
Verified March 2012 by Spanish Lung Cancer Group
Sponsor:
Spanish Lung Cancer Group
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00478699
First received: May 24, 2007
Last updated: December 13, 2012
Last verified: March 2012
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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 3 |
| 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:
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: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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
Show 51 Study Locations
Contacts
| Contact: Eva Pereira | +34 93 430 20 06 | epereira@gecp.org |
Show 51 Study LocationsSponsors 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 DE LA PRINCESA |
More Information
Additional Information:
No publications provided
| Responsible Party: | 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: | December 13, 2012 |
| 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 May 23, 2013