Paclitaxel plus S-1 (TS) versus oxaliplatin and S-1(SOX) for treatment of advanced diffuse-type gastric cancer: a multicenter, randomised ,controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003139

Enrollment

Unknown

Registered

2013-02-22

Start date

2013-03-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced diffuse-type gastric cancer

Interventions

test group:Paclitaxel plus S-1

control group:Oxaliplatin plus S-1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. histologically confirmed unresectable locally advanced or metastatic diffuse-type adenocarcinoma of the stomach or gastroesophageal junction; 3. Life expectancy>=3 months; 4. Performance status (ECOG scale): 0-2; 5. No less than one measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria, version 1.1; 6. No Prior systemic therapy; 7.(Neo)adjuvant chemotherapy, if given,was permitted if completed >=6 months without paclitaxel, S-1 and oxaliplatin or >=12 months with paclitaxel, S-1 or oxaliplatin before randomization assignment; 8. Patients with adequate bone marrow, hepatic, and renal function as the following: absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=80,000/mm3, hemoglobin >8 g/dL; total bilirubin<= 2.5 times upper limit of reference ranges (ULRR); AST and ALT <=2.5 times ULRR (<=5 times ULRR if liver metastases); alkaline phosphatase<= 2.5 times ULRR (<= 10 times ULRR if bone metastases); serum creatinine<=1.5 times ULRR; 9. Patients should sign a written informed consent before study entry.

Exclusion criteria

Exclusion criteria: 1. Patients with known sensitivity to paclitaxel, S-1 or oxaliplatin; 2. Patients with obvious unusual hemoglutination mechanism,active bleeding or bleeding tendency; 3. Other prior malignancyexcept adequately treated basal cell or carcinoma in situ of the cervix; 4. Presence of CNS metastasis; 5. No other lesion except bone metastases, malignant hydrothorax or ascites; 6. Patients with uncontrolled systemic disease, acute infection or myocardial infarction <=3 months; 7. Pregnant or lactating woman; 8. Unsuitable patients judged by investigators.

Design outcomes

Primary

Measure	Time frame
PF;	—

Secondary

Measure	Time frame
os;OR;	—

Countries

China

Contacts

Public ContactFeng Bi

bifeng@medmail.com.cn+86 18980601771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026