- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839032
Oral Vinorelbine as Induction Chemotherapy Followed Concomitant Chemoradiotherapy
A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Caen, France, 14033
- CHU Caen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- histologically or cytologically confirmed stage IIIA (only N2),
- dry IIIB previously untreated inoperable NSCLC,
- 18 to 75 years old,
- Karnofsky Performance Status (KPS) ≥ 80%,
- weight loss ≤ 10% within the previous 3 months,
- normal organ functions were eligible.
- at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) [10].
Exclusion Criteria:
- stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,
- pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures
- Symptomatic Neuropathy > grade 1,
- associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),
- other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,
- Previous treatment with an other antineoplasic,
- Known hypersensibility to drugs with a similar chemical structure ti this studied.
- important malabsorbtion syndrom or disease of gastro-intestinal track,
- Participation to another clinical trial within 30 days before inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vinorelbine cisplatin radiotherapy
Induction period + radio chemotherapy
|
During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8. Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease controle
Time Frame: up to 3 years
|
up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- duration of response (DR)
Time Frame: up to 3 years
|
Secondary endpoints were duration of response (DR), progression-free survival (PFS), and overall survival (OS), calculated by the Kaplan-Meier method.
The safety analysis reported the worst grade of the adverse events (NCI CTC v. 2.0) for the safety population.
|
up to 3 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- progression-free survival (PFS)
Time Frame: up to 3 years
|
up to 3 years
|
- overall survival (OS),
Time Frame: up to 3 years
|
up to 3 years
|
- safety
Time Frame: up to 3 years
|
up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gérard Zalcmann, professor, Baclesse, Caen, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Cisplatin
- Vinorelbine
Other Study ID Numbers
- 041316
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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