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Sponsored by: |
Johannes Gutenberg University Mainz |
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Information provided by: | Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT00532025 |
This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC.
The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. For sample size calculation a 2 year PFS of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated for the intervention group. These estimates are based on the actual PFS and overall survival (OS) of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to published international results, and the improvement of PFS achieved by 4 cycles of cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-Small Cell Lung Carcinoma (NSCLC) in Patients Not Eligible for Cisplatin-Based Adjuvant Chemotherapy |
Estimated Enrollment: | 134 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sorafenib treatment
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Drug: Sorafenib
Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9 g/dL INR < 1.5 ULN and PTT within normal limits Hepatic: total bilirubin < 1.5 x ULN, AST or ALT < 2.5 x ULN Renal: creatinine < 1.5 x ULN
Exclusion Criteria:
Germany | |
SIRN investigational trial site Johannes Gutenberg Universität | |
Mainz, Germany | |
SIRN investigational trial site | |
Halle (Saale), Germany | |
SIRN investigational trial site | |
Loewenstein, Germany | |
SIRN investigational trial site Katholisches Klinikum | |
Mainz, Germany | |
SIRN investigational trial site | |
Essen, Germany | |
SIRN investigational trial site | |
Rotenburg (Wuemme), Germany |
Principal Investigator: | Martin Schuler, MD | Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum, Universitätsklinikum Essen, Hufelandstrasse 55, 45122 Essen |
Responsible Party: | University ( Prof. Martin Schuler ) |
Study ID Numbers: | SIRN-TOM1 KKS 2006-010 |
Study First Received: | September 18, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00532025 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Sorafenib NSCLC Adjuvant Treatment resected Non-Small Cell Lung Carcinoma |
Thoracic Neoplasms Disulfiram Adjuvants, Immunologic Protein Kinase Inhibitors Carcinoma Respiratory Tract Diseases Cisplatin |
Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |