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

This study has been completed.
Sponsor:
Collaborator:
Fabre Clinic
Information provided by:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00295672
First received: February 23, 2006
Last updated: July 24, 2009
Last verified: July 2009
  Purpose

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.

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Condition Intervention Phase
Lung Neoplasm
Drug: Vinorelbine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • TUMORAL RESPONSE (RECIST)
  • TOXICITY (NCI 20)

Secondary Outcome Measures:
  • SURVIVAL
  • TIME TO PROGRESSION
  • LATE RADIATION TOXICITY

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: June 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295672

Locations
France
CHU of Brest
Brest, France, 29250
CH GAP
GAP, France, 05000
CHU de LIMOGES
Limoges, France, 87042
Hopital de la Croix Rousse
Lyon, France, 69317
Hôpital Sainte Margueritte
Marseilles, France, 13274
CHU Hôpital Nord
Saint Etienne, France, 42055
Sponsors and Collaborators
University Hospital, Brest
Fabre Clinic
Investigators
Principal Investigator: gilles Robinet CHU of Brest
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00295672     History of Changes
Other Study ID Numbers: RB 05-110, VINCR - GFPC 05-03
Study First Received: February 23, 2006
Last Updated: July 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Non-Small-Cell Lung,radiotherapy, Chemotherapy, vinorelbine

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 22, 2014