The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531452
• Other study ID #: CH-GI-016
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2012
• Last updated: December 3, 2014
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

Description:

There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma

• Measurable lesion and/or non-measurable lesion defined by RECIST

• ECOG performance status ? 1

• Hgb ? 8g/dL, WBC 4000-12000/mm3, platelets ? 100,000/mm3

• Creatine ? upper normal limit (UNL)

• Total bilirubin ? 1.5 X UNL

• AST, ALT and ALP ? 2.5 x UNL

• Subjects must be able to take orally

• No prior chemotherapy

• Life expectancy estimated than 3 months

• Written informed consent

Exclusion Criteria:

• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

• Known brain metastases

• History of hypersensitivity to fluoropyrimidines, oxaliplatin

• Active double cancer

• Treatment with any investigational product during the last 4 weeks prior to study entry

• Symptomatic peripheral neuropathy ? garde 2. by NCI-CTCAE ver.3.0

• Any previous chemotherapy or radiotherapy for AGC

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
130mg/m2 d1,repeated q21d
• s1
80mg/m2/d, d1-14,repeated q21d

Locations

Country	Name	City	State
China	cancer hospital & Institute,Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks	2 years	No
Secondary	Response Rate	From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles	2 years	No
Secondary	overall survival	From date of treatment was administered until the date of death from any cause,assessed every 3 months	2 years	No
Secondary	number of participants with adverse events	assessed from treatment was administered until 1 months after withdrawing from study	2 years	Yes