Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy in Locally Advanced NSCLC.

Lung Neoplasm Clinical Trial

— VINCR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295672
• Other study ID #: RB 05-110
• Secondary ID: VINCR - GFPC 05-
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2006
• Last updated: July 24, 2009
• Start date: February 2006
• Est. completion date: June 2007

Study information

• Verified date: July 2009
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

About one-third of patients with non-small-cell lung cancer (NSCLC) have inoperable, locally advanced stage III disease at diagnosis. The most satisfactory treatment for patients with locally advanced NSCLC is combination chemotherapy-radiotherapy (CT-RT). However, the optimal interval between irradiation and chemotherapy as well as the most effective chemotherapy protocol remains to be defined.

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.

Patients will be enrolled in the study by members of GFPC, a French cooperative group on thoracic oncology. The main eligibility criteria are : 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. Induction chemotherapy will comprise two cycles of cisplatin 80mg/m2 and docetaxel 75mg/m2 (given on D1 and D22). Concomitant CT-RT will start on D57. Radiotherapy will occur from D57 until D99 (2 Gy/day, 5 days/week, total dose is 66 Gy). Cisplatin 80mg/m2 will be given on D57 (first day of irradiation) and D78. Oral vinorelbine 40 mg/m2 will be administered on D57, D64, D78 and D85. The main endpoint is the objective response rate. The tumor response will be assessed first at the end of induction chemotherapy, and again 4 weeks after concurrent CT-RT. Patients who will progress after induction chemotherapy will leave the study. Those with stable disease or a tumor response will receive the CT-RT combination. Tolerability, time until progression, duration of response and proportion of survival at 1, 2 and 3 years represent a secondary endpoints. The study will be achieved according to the French legislation and guidelines for biomedical research involving human subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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,

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Drug:
• Vinorelbine

Locations

Country	Name	City	State
France	CHU of Brest	Brest
France	CH GAP	GAP
France	CHU de LIMOGES	Limoges
France	Hopital de la Croix Rousse	Lyon
France	Hôpital Sainte Margueritte	Marseilles
France	CHU Hôpital Nord	Saint Etienne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Fabre Clinic

Country where clinical trial is conducted

France, 

References & Publications (2)

Fournel P, Robinet G, Thomas P, Souquet PJ, Léna H, Vergnenégre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daurés JP, Mornex F, Pérol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie. 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 Français de Pneumo-Cancérologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. Epub 2005 Aug 8. — View Citation

Vergnenègre A, Daniel C, Léna H, Fournel P, Kleisbauer JP, Le Caer H, Letreut J, Paillotin D, Pérol 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TUMORAL RESPONSE (RECIST)
Primary	TOXICITY (NCI 20)
Secondary	SURVIVAL
Secondary	TIME TO PROGRESSION
Secondary	LATE RADIATION TOXICITY

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