Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection
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
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: S1 capsule Type: Drug
Name: Vinorelbine Type: Drug
Overall Status
Not yet recruiting
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
Jun Feng Liu
Shijiazhuang, Hebei, China
Status: Not yet recruiting
Contact: Xin-Bo Liu, MD - +86-311-86095353 -
Start Date
December 2014
Completion Date
December 2018
Hebei Medical University Fourth Hospital
Hebei Medical University Fourth Hospital
Record processing date processed this data on July 28, 2015 page