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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Peking University
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Shen Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01679340
First received: June 13, 2012
Last updated: September 2, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: S-1
Drug: oxaliplatin
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • replase free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: April 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679340

Contacts
Contact: Shen Lin, professor 010-88196561 xiaotong10241@sina.com

Locations
China, Bejing
Beijing Cancer Hospital Recruiting
Beijing, Bejing, China, 100142
Contact: Shen Lin, Professor    010-88196561    xiaotong10241@sina.com   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University
Taiho Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Shen Lin, Director of GI oncology, Peking University
ClinicalTrials.gov Identifier: NCT01679340     History of Changes
Other Study ID Numbers: SOXSP
Study First Received: June 13, 2012
Last Updated: September 2, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Gastric cancer
D2 surgery
S-1
Oxaliplatin
cisplatin

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 29, 2014