Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Lung Cancer Group
• Treatments: Cisplatin; Docetaxel; Gemcitabine

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.