Clinical trial · Interventional
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
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
NCT00478699CI-TRIAL-00083640GECP-SCATcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Docetaxel/Cisplatin | Drug | — | UNRESOLVED |
| Docetaxel/Cisplatin control | Drug | — | UNRESOLVED |
| Gemcitabine/Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 Control group
- description
- Control group: \*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
- interventionNames
- Drug: Docetaxel/Cisplatin control
- type
- EXPERIMENTAL
- label
- 2 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.
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine/Cisplatin
- Drug: Docetaxel/Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.