Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection (S1VSNP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer Stage ⅢA; Non-small Cell Lung Cancer Stage Ⅱ
• Intervention / Treatment: Drug: S1 capsule; Drug: Vinorelbine

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Jun Feng Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S1 capsule plus Cisplatin; 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; 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.; Other Names: S1: Gimeracil and oteracil porassium capsules; Cisplatin: Cisplatin for injection
Active Comparator: Vinorelbine plus Cisplatin; Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles	Drug: Vinorelbine; 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.; Other Names: Cisplatin: Cisplatin for injection; Vinorelbine: Navelbine,vinorelbine bitartrate injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular marker measurement for NSCLC	The measured molecular markers include carcinoembryonic antigen (CEA), tissue polypeptide specific antigen (TPS), neuron-specific enolase (NSE), carbohydrate antigen 199 (CA199), cytokeratin fragment 19 ( CYFRA 21-1), and squamous cell carcinoma antigen (SCC Ag)	Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Jun-Feng Liu, Professor, Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Cisplatin; Vinorelbine
• Other Study ID Numbers: HBMF9990