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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01679340

Collaborator

Taiho Pharmaceutical Co., Ltd. (Industry)

160

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

replase free survival [3 months]

Secondary Outcome Measures

overall survival [6 months]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.