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

NCT02223611 | Unknown Phase 2 DMC

• 1 other identifier: HBMF9990
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection

Outcome Measures

Primary Outcomes (1)

• Disease free survival rate

  2 years

Secondary Outcomes (4)

• Disease free survival

  4 years

• Overall survival

  4 years

• 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.

• Quality of life (QOL)

  Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

Other Outcomes (1)

• Molecular marker measurement for NSCLC

  Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence

Study Arms (2)

S1 capsule plus Cisplatin

EXPERIMENTAL

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

Vinorelbine plus Cisplatin

ACTIVE COMPARATOR

Vinorelbine: 25 mg/m2 intravenously on day 1, and day 8. Cisplatin: 75 mg/m2 intravenously on day 1. 3 weeks/4cycles

Drug: Vinorelbine

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.

Also known as: S1: Gimeracil and oteracil porassium capsules, Cisplatin: Cisplatin for injection

S1 capsule plus Cisplatin

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.

Also known as: Vinorelbine: Navelbine,vinorelbine bitartrate injection, Cisplatin: Cisplatin for injection

Vinorelbine plus Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Systemic anticancer treatment
• local radiotherapy

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Jun Feng Liu

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Interventions

S 1 (combination); Cisplatin; Injections; Vinorelbine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Jun-Feng Liu, Professor

  Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Feng Liu, Professor

CONTACT

+86-311-86095353; liujf@heinfo.net

Yun Jiang Liu, Professor

CONTACT

+86-13703297890; lyj818326@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 22, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

CN (1)