Treatment of Chinese patients with metastatic gastric cancer where resection is not possible

Treatment of Chinese patients with metastatic gastric cancer where resection is not possible, with a biweekly combination of S-1 and Paclitaxel (SPA) or a combination of S-1 and Oxaliplatin (SOX)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85705844

Enrollment

100

Registered

2011-04-15

Start date

2010-03-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Metastatic gastric cancer or where resection is not possible Cancer Metastic gastric cancer

Interventions

1. Patients were randomized (1:1) according to the following sequences: 1.1. Arm A: S-1 was administered orally (80 mg/m2/day) after meal for 7 days followed by a 7-day rest every 2 weeks with Paclit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable or metastatic gastric cancer were eligible for this study 2. Patients were required to have histological or cytological proof of locally advanced or metastatic transitional cell carcinoma of the bladder, ureter or renal pelvis 3. Prior cytotoxic treatment in the adjuvant setting was permitted if the treatment had been completed at least six months prior to enrollment in the study 4.Prior radiotherapy was permitted but must have been completed at least six weeks prior to enrollment 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 6. A life expectancy at least 4 months 7. Age between 18 and 75 years 8.Adequate bone marrow: absolute neutrophil count more than or equal to 1.5x10E9/L platelet count more than or equal to 100x10E9/L,and hemoglobin more than or equal to 90g/L 9. Adequate hepatic functions: aspartate aminotransferase (AST) and (alanine aminotransferase) ALT less than or equal to 3.0 times the upper normal limit (UNL) and serum bilirubin less than or equal to 1.5 10. Adequate renal functions: serum creatinine less than or equal to 133umol/L 11. Adequate normal cardiac function

Exclusion criteria

Exclusion criteria: 1. Second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma 2. Central nervous system (CNS) involvement 3. Prior radiotherapy in parameter lesions 4. Concurrent uncontrolled medical illness

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
1. Overall survival 2. Response rate 3. Safety	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026