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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01679340
• Other study ID #: SOXSP
• Status: Recruiting
• Phase: Phase 2
• First received: June 13, 2012
• Last updated: May 17, 2015
• Start date: April 2011
• Est. completion date: June 2018

Study information

• Verified date: May 2015
• Source: Peking University
• Contact: Shen Lin, professor
• Phone: 010-88196561
• Email: xiaotong10241[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
• oxaliplatin
Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
• cisplatin
Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	replase free survival		3 months	No
Secondary	overall survival		6 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months	Yes