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

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: Gastric Cancer
• Intervention / Treatment: Drug: S-1; Drug: oxaliplatin; Drug: cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Shen Lin, Professor; Phone Number: 010-88196561; Email: xiaotong10241@sina.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Taiho Pharmaceutical Co., Ltd.

Study record dates

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: cisplatin; Gastric cancer; S-1; Oxaliplatin; D2 surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: SOXSP