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

NCT01531452 | Completed Phase 2

• 1 other identifier: CH-GI-016
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasms; drug therapy; oxaliplatin; s1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Response Rate

  2 years

• overall survival

  2 years

• number of participants with adverse events

  2 years

Study Arms (1)

treatment

EXPERIMENTAL

oxaliplatin+s1

Drug: Oxaliplatin; Drug: s1

Interventions

Oxaliplatin DRUG

130mg/m2 d1,repeated q21d

Also known as: eloxatin

treatment

s1 DRUG

80mg/m2/d, d1-14,repeated q21d

Also known as: TS-1

treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

cancer hospital & Institute,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Jinwan Wang, MD

  cancer hospital&institute,Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 13, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

CN (1)