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

Peking University

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: oxaliplatin; Drug: S-1; Drug: cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01679340

SOXSP

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

S-1+oxaliplatin

Experimental group

Description:

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.

Treatment:

Drug: S-1

Drug: oxaliplatin

S-1+cisplatin

Active Comparator group

Description:

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.

Treatment:

Drug: cisplatin

Drug: S-1