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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase ⅡTrial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage Ⅱ-ⅢA Non-small Cell Lung Cancer (NSCLC) After Complete Resection

Conditions
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Non-small Cell Lung Cancer Stage Ⅱ, Non-small Cell Lung Cancer Stage ⅢA

Intervention / Treatment
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* Drug: S1 capsule
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S1 capsule plus Cisplatin<br>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 | Drug: S1 capsule<br>* Within four weeks after the completely resection, S-1 was administered orally twice a day, after meals on days 1 to 14. The actual dose of S-1 was selected as follows: in a patient with body surface area (BSA)<1.25 m2 40mg twice a day, 1.25 m2≤BSA<1.5 m2 50mg twice a day, and 1.5 m2≤BSA 60mg twice a day. Cisplatin (75 mg/m2) was administered intravenously on day 1 The treatment regimen was repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.<br>* Other names: Cisplatin: Cisplatin for injection;|
| Active Comparator: Vinorelbine plus Cisplatin<br>Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles | Drug: Vinorelbine<br>* Vinorelbine (25 mg/m2) is administered intravenously on day 1, and day 8. Cisplatin (75 mg/m2) is administered intravenously on day 1. The treatment regimen is repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.<br>* Other names: Cisplatin: Cisplatin for injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival rate |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection