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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01679340
Recruitment Status : Unknown
Verified May 2015 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : May 19, 2015
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: S-1 Drug: oxaliplatin Drug: cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery
Study Start Date : April 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

Primary Outcome Measures :
  1. replase free survival [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 6 months ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01679340

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Contact: Shen Lin, professor 010-88196561

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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University
Taiho Pharmaceutical Co., Ltd.
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Responsible Party: Shen Lin, Director of GI oncology, Peking University Identifier: NCT01679340    
Other Study ID Numbers: SOXSP
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Keywords provided by Shen Lin, Peking University:
Gastric cancer
D2 surgery
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents