Clinical trial · Interventional
Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC
NCT01771289CI-TRIAL-00024038unknownPhase 2ClinicalTrials.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)
The purpose of this study was to evaluate the safety and efficacy of neoadjuvant concurrent chemoradiation with weekly docetaxel/cisplatin in patients with resectable IIIA-N2 NSCLC.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel/cisplatin | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemoradiation
- interventionNames
- Drug: docetaxel/cisplatin
- Radiation: Radiation
Primary outcomes (1)
- measure
- downstage rate of mediastinal lymph nodes
- timeFrame
- 8 weeks
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 5y
- measure
- Disease-free survival
- timeFrame
- 5y
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years older. * Present with histologically proven or cytological diagnosis of NSCLC Stage IIIA as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is amenable to surgery. * No prior systemic chemotherapy or targeted therapy for lung cancer before screening. * ECOG performance status of 0 or 1. * Life expectancy ≥12 weeks. * Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level). * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases. * Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min. * Female subjects should not be pregnant or breast-feeding. Exclusion Criteria: * Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). * Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). * History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Known hypersensitivity to Tarceva or gemcitabine or cisplatin. * Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this. * Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
References
Publications (0)
Data not yet available
No reference posted for this study.