Clinical trial · Interventional
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC
- 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)
Primary objective: * To classify the 2 study groups, according to the tumoral response. Secondary objectives: * To evaluate the percentage of focused control per year. * To calculate the time until progression. * To evaluate the safety profile.
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 |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine | Drug | — | UNRESOLVED |
| Docetaxel + gemcitabine + carboplatin + radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine
- interventionNames
- Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine
- type
- EXPERIMENTAL
- label
- 2
- description
- docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel
- interventionNames
- Other: Docetaxel + gemcitabine + carboplatin + radiotherapy
Primary outcomes (1)
- measure
- Response rate in each arm measured according to RECIST criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non small cell lung cancer confirmed by histology or by cytology. * IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation * General stage 0-1 at the ECOG scale * Loss of weight less than 5% in the 3 previous months from diagnose. * Pulmonary function and gasometry results: FEV1 \> 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) \> 30%, PCO2 \< 45 mmHg and PO2 \> 60 mmHg. * Normal medullar function (hemoglobin \> 11 g/dl, total WBC \> 1,5 x 10\^9/l, platelets \> 100 x 10\^9/l) * Appropriate renal and hepatic functions * CTScan * Anticonceptive method * Available laboratory test (maximum 1 month before) Exclusion criteria: * Pleural discharge, upper cava vein syndrome or supraclavicular affectation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available