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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295672
First Posted: February 24, 2006
Last Update Posted: July 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fabre Clinic
Information provided by:
University Hospital, Brest
  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.


Condition Intervention Phase
Lung Neoplasm Drug: Vinorelbine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 23, 2006
First Posted: February 24, 2006
Last Update Posted: July 28, 2009
Last Verified: July 2009

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
Vinblastine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action