Phase 3
N=500
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
Non-small-cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00478699 ↗Enrolled (actual)
500
Serious AEs
20.4%
Results posted
Dec 2024
Primary outcome: Primary: Estimated Overall Survival — 0.54; 0.56; 0.54; 0.56 proportion of participants — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Docetaxel/Cisplatin control (Drug); Docetaxel (Drug); Gemcitabine/Cisplatin (Drug); Docetaxel/Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spanish Lung Cancer Group
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Overall Survival |
0.54; 0.56; 0.54; 0.56; 0.54; 0.53 | 0.73 |
| SECONDARY Disease Free Survival |
38.7; 32.7 | 0.753 |
Summary
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00478699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.