A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

May 17, 2015 updated by: Shen Lin, Peking University

Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery

To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
  • without previous treatment, including radiotherapy, chemotherapy and immunotherapy
  • Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
  • creatinine≤1 UNL
  • total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
  • ECOG score 0 - 2
  • take chemotherapy for 8 weeks after surgery
  • older than 18 years
  • can be followed up, good compliance
  • can take medicine orally
  • having signed informed consent

Exclusion Criteria:

  • combined disease lead to Life Expectancy less than 3 years
  • any evidence to show metastasis,including cancer cells in peritoneal fluid
  • inability to take oral medication for difficult to swallow, intestinal obstruction，active intestinal blooding or perforation
  • previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone）
  • operation within 4 weeks, or not recovered from last major operation
  • allergy with fluorouracil
  • allergy with Platinum or any composition in research drugs
  • uncontrollable seizure disorder，central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
  • in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
  • pregnancy， lactation， women in child-bearing period and her spouses reject to take effictive method to conraception
  • other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
  • peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex（DTRs）.
  • serious complicated infection or other complicated diseases and hard to controll.
  • As one of belowing:
  • ANC < 2×109/L
  • Platelet<100×109/L
  • total bilirubin>1.5 UNL
  • ALAT、ASAT > 2.5 x ULN
  • ALP> 2.5 x ULN
  • Any investigational agent within the past 28 days. That is the patient had jioned another trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1+oxaliplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
Drug: S-1
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
Other Names:
  • TS-1
  • Aisiwan
Drug: oxaliplatin
Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
Active Comparator: S-1+cisplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
Drug: S-1
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
Other Names:
  • TS-1
  • Aisiwan
Drug: cisplatin
Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
replase free survival
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 months
6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Taiho Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

September 2, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOXSP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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