Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection
Conditions
Non-small Cell Lung Cancer Stage Ⅱ - Non-small Cell Lung Cancer Stage ⅢA
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S1 capsule Type: Drug
Name: Vinorelbine Type: Drug
Overall Status
Not yet recruiting
Summary
The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.
Detailed Description
Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.

For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.

S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)

- Must be able to receive the therapy of the study within four weeks after the completely resection

Exclusion Criteria:

- Systemic anticancer treatment

- local radiotherapy
Location
Jun Feng Liu
Shijiazhuang, Hebei, China
Status: Not yet recruiting
Contact: Xin-Bo Liu, MD - +86-311-86095353 - lxbbbsj@163.com
Start Date
December 2014
Completion Date
December 2018
Sponsors
Hebei Medical University Fourth Hospital
Source
Hebei Medical University Fourth Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page