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

Non-small Cell Lung Cancer Stage ?A Clinical Trial

— S1VSNP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02223611
• Other study ID #: HBMF9990
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 14, 2014
• Last updated: August 21, 2014
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2014
• Source: Hebei Medical University Fourth Hospital
• Contact: Jun Feng Liu, Professor
• Phone: +86-311-86095353
• Email: liujf[@]heinfo.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient with completely resected stage ?A 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage ?
• Non-small Cell Lung Cancer Stage ?A

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Jun Feng Liu	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Disease free survival rate		2 years	No
Secondary	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	No
Secondary	Overall survival	The period from the date of enrollment to the date of death from any cause.	4 years	No
Secondary	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.	Yes
Secondary	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.	No