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

NCT ID: NCT01679340

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles

oxaliplatin

Intervention Type: DRUG

Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles

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.

Group Type: ACTIVE_COMPARATOR

S-1

Intervention Type: DRUG

Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles

cisplatin

Intervention Type: DRUG

Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle

Interventions

S-1

Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles

Intervention Type: DRUG

oxaliplatin

Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles

Intervention Type: DRUG

cisplatin

Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle

Intervention Type: DRUG

Other Intervention Names

TS-1; Aisiwan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Director of GI oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shen Lin, professor

Role: CONTACT

xiaotong10241@sina.com

010-88196561

Facility Contacts

Shen Lin, Professor

Role: primary

xiaotong10241@sina.com

010-88196561

Other Identifiers

SOXSP

Identifier Type: -

Identifier Source: org_study_id