Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Spanish Lung Cancer Group

Status and phase: Completed; Phase 3

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: Docetaxel; Drug: Gemcitabine/Cisplatin; Drug: Docetaxel/Cisplatin control; Drug: Docetaxel/Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00478699

GECP-SCAT

2007-000067-15 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

1 Control group

Active Comparator group

Description:

Control group: \*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.

Treatment:

Drug: Docetaxel/Cisplatin control

2 Experimental group

Experimental group

Description:

Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments: * Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4 * Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4. * High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.

Treatment:

Drug: Docetaxel/Cisplatin

Drug: Gemcitabine/Cisplatin

Drug: Docetaxel