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

NCT02223611 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-08-22

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Principal Investigators

  • Jun-Feng Liu, Professor · Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223611 on ClinicalTrials.gov