Clinical trial · Interventional
Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy in Locally Advanced NSCLC.
Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy With Cisplatin-docetaxel in Patients With Locally Advanced Non-small-cell Lung Cancer. A Multicenter Phase II Trial
- 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)
Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous form because: 1- Previous investigations have demonstrated that oral vinorelbine is as effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of oral agents in CT will reduce some disagreements provoked by intravenous injections: stress, infections, hemorrhage, displacement at the hospital and cost of CT. .
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 Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- TUMORAL RESPONSE (RECIST)
- measure
- TOXICITY (NCI 20)
Secondary outcomes (3)
- measure
- SURVIVAL
- measure
- TIME TO PROGRESSION
- measure
- LATE RADIATION TOXICITY
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: histologically or cytologically documented inoperable stage IIIA N2 or IIIB NSCLC previously untreated, absence of malignant pleural effusion, performance status (PS) =1 and patient life expectancy of at least 12 weeks. Exclusion Criteria: metastatic disease, small Cell lung carcinoma, prior chemotherapy, prior radiotherapy, resecable tumor, any instable systemic disease, any other malignancies within 5 years,
References
Publications (2)
- BACKGROUNDFournel P, Robinet G, Thomas P, Souquet PJ, Lena H, Vergnenegre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daures JP, Mornex F, Perol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. doi: 10.1200/JCO.2005.03.070. Epub 2005 Aug 8. PMID 16087956
- BACKGROUNDVergnenegre A, Daniel C, Lena H, Fournel P, Kleisbauer JP, Le Caer H, Letreut J, Paillotin D, Perol M, Bouchaert E, Preux PM, Robinet G; Groupe Francais de Pneumo-Cancerologie. Docetaxel and concurrent radiotherapy after two cycles of induction chemotherapy with cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer. A phase II trial conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC). Lung Cancer. 2005 Mar;47(3):395-404. doi: 10.1016/j.lungcan.2004.08.010. PMID 15713523