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Sponsors and Collaborators: |
Pierre Fabre Medicament Pierre Fabre Pharma GmbH |
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Information provided by: | Pierre Fabre Medicament |
ClinicalTrials.gov Identifier: | NCT00683514 |
This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC). The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.
Condition | Intervention | Phase |
---|---|---|
NSCLC |
Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized Phase III Study |
Estimated Enrollment: | 360 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A
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Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
q 28 days :
q 21 days :
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B
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Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
q 28 days :
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contact: Johannes EISINGER, MD | 49-761-45261-851 | johannes.eisinger@pierre-fabre.de |
Contact: Susanne OSOWSKI, CRA | 49-761-45261-853 | susanne.osowski@pierre-fabre.de |
Germany, Jechtinger Str. 13 | |
Pierre Fabre Pharma GmbH | Recruiting |
Freiburg, Jechtinger Str. 13, Germany, D-79111 | |
Contact: Johannes EISINGER, MD 49-761-45261-851 johannes.eisinger@pierre-fabre.de | |
Contact: Susanne OSOWSKI, CRA 49-761-45261-853 susanne.osowski@pierre-fabre.de |
Study Director: | Marcello RIGGI, Clinical Development Director | Institut de Recherche Pierre Fabre |
Responsible Party: | Institut de Recherche Pierre Fabre ( Marcello RIGGI, MD ) |
Study ID Numbers: | PM 0259 CA 304 J1 |
Study First Received: | May 21, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00683514 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy |
Thoracic Neoplasms Vinorelbine Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Vinorelbine |
Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |