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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
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
Donga university hospital
Busan, South Korea
RECRUITINGUlsan University Hospital
Ulsan, South Korea
RECRUITINGRelapse-free survival
RFS was defined as the time from the date of surgery to relapse or death from any cause.
Time frame: 3 years from enrollment.
Overall survival
OS was defined as the time from the date of surgery to death from any cause.
Time frame: 3 years from enrollment.
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