Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Pierre Fabre Medicament.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Pierre Fabre Medicament
Collaborator:
Pierre Fabre Pharma GmbH
Information provided by:
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT00683514
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: May 2008
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pierre Fabre Medicament:
Primary Outcome Measures:
- Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria [ Time Frame: at baseline and every 2 treatment cycles and Regular Follow Up at 2 months intervals during the 1st year after completion of treatment and then every 3 months until progression of the last evaluable patient ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of mesurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria, LCSS QOL Questionnaire and Physical Examination [ Time Frame: At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
A
|
Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
q 28 days :
q 21 days :
|
B
|
Drug: Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
q 28 days :
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Presence of at least one measurable lesion (RECIST criteria)
- Patients with a Karnofsky Performance Status = or > 80%
- Adequate pulmonary function, bone marrow, hepatic and renal functions
Main Exclusion Criteria:
- Patients with NSCLC stage IV, with NSCLC stages I, II, IIIA (except N2), with NSCLC stage IIIB with tumour extent or pleural effusion
- Symptomatic neuropathy > Grade 1
- Hearing impairment = or > Grade 2
- Concomitant/uncontrolled medical disorder
- Pregnant women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683514
Contacts
| 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 |
Locations
| Germany | |
| 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 | |
Sponsors and Collaborators
Pierre Fabre Medicament
Pierre Fabre Pharma GmbH
Investigators
| Study Director: | Marcello RIGGI, Clinical Development Director | Institut de Recherche Pierre Fabre |
More Information
No publications provided
| Responsible Party: | Marcello RIGGI, MD, Institut de Recherche Pierre Fabre |
| ClinicalTrials.gov Identifier: | NCT00683514 History of Changes |
| Other Study ID Numbers: | PM 0259 CA 304 J1 |
| Study First Received: | May 21, 2008 |
| Last Updated: | May 22, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Pierre Fabre Medicament:
|
Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Vinorelbine Cisplatin |
Vinblastine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013