NCT01426646

S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer

Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory results. The majority of randomized clinical trials studying adjuvant chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric cancer patients who underwent curative resection with extended lymph-node dissection (D2), may be valid in countries where D2 surgery is considered the standard of care. S-1 improved the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%, respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further investigation is needed for more effective postoperative treatment of patients with stage IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected gastric adenocarcinoma.

Detailed description

This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days after curative resection. To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	S-1	S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
DRUG	S-1 plus cisplatin	S-1 plus cisplatin every 3 weeks, a total of eight cycles * S-1: 40mg/m2 orally twice daily (days 1-14) * Cisplatin: 60mg/m2 IV on day 1

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2016-09-01
• First posted: 2011-08-31
• Last updated: 2012-01-05

Locations

2 sites across 1 country: South Korea