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

NCT01679340 | Unknown Phase 2 DMC

• 1 other identifier: SOXSP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Gastric cancer; D2 surgery; S-1; Oxaliplatin; cisplatin

Outcome Measures

Primary Outcomes (1)

• replase free survival

  3 months

Secondary Outcomes (2)

• overall survival

  6 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  3 months

Study Arms (2)

S-1+oxaliplatin

EXPERIMENTAL

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; Drug: oxaliplatin

S-1+cisplatin

ACTIVE COMPARATOR

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; Drug: cisplatin

Interventions

S-1 DRUG

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

Also known as: TS-1, Aisiwan

S-1+cisplatin; S-1+oxaliplatin

oxaliplatin DRUG

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

S-1+oxaliplatin

cisplatin DRUG

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

S-1+cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); titanium silicide; Oxaliplatin; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Shen Lin, professor

CONTACT

010-88196561; xiaotong10241@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of GI oncology

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: September 6, 2012
• Study Start: April 1, 2011
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

CN (1)