Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection

Phase 2

• Conditions: Non-small Cell Lung Cancer Stage ⅢA; Non-small Cell Lung Cancer Stage Ⅱ
• Interventions: Drug: S1 capsule; Drug: Vinorelbine

• Registration Number: NCT02223611
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief 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.

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-22
• Last Update Posted: 2014-08-22
• Study Start: 2014-12
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S1 capsule plus Cisplatin	S1 capsule	S1: 40mg, bid, when body surface area (BSA)\<1.25 m2, 50mg; bid when 1.25 m2≤BSA\<1.5 m2; 60mg, bid when 1.5 m2≤BSA 60mg from day 1 to 14. Cisplatin: 75 mg/m2 on day 1. 3 weeks/4cycles
Vinorelbine plus Cisplatin	Vinorelbine	Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles

Primary Outcome Measures

Name	Time	Method
Disease free survival rate	2 years

Secondary Outcome Measures

Name	Time	Method
Disease free survival	4 years	The period from the date of enrollment to the date on which the recurrence was first confirmed. For patients who died before disease progression from any cause, death was attributed to recurrence.
Overall survival	4 years	The period from the date of enrollment to the date of death from any cause.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.	The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 4.0.
Quality of life (QOL)	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.	QOL was assessed with the lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale(LCSS).

Trial Locations

Locations (1)

Jun Feng Liu; 🇨🇳 Shijiazhuang, Hebei, China