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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT02223611
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small Cell Lung Cancer Stage Ⅱ
  • Non-small Cell Lung Cancer Stage ⅢA

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • S1 capsule — DRUG
    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.
  • Vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
Aug 2014
Primary completion
Dec 31, 2016
Completion
Dec 31, 2018

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Disease free survival rate [ Time Frame: 2 years ]

Central Contacts