Maintenance Treatment With S-1 in Gastric Cancer Patients
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
Gastric cancer remains the third leading cause of cancer-related death worldwide and is
especially frequent in East Asia. Fluoropyrimidines are the backbone of first-line
chemotherapy for advanced gastric cancer (AGC), and S-1 provides new option with its
simplicity and convenience.
5-Fluorouracil (5-FU) was the only efficacious treatment for AGC before the nineties of the
20th century, and afterwards with the discovery of chemotherapy such as cisplatin,
oxaliplatin, S-1 and capecitabine, response rate as well as survival had been improved
greatly.
Most of AGC will progress after first-line treatment; therefore, seeking an efficient and low
toxic maintaining regimen to prolong progression-free survival (PFS) becomes a hot topic in
oncologic field. Some clinical researches demonstrated maintenance treatment for advanced
colorectal cancer (CRC) and lung cancer. The investigators had conducted a phase III clinical
trial that demonstrated capecitabine maintenance versus observation prolonged PFS
significantly after first-line chemotherapy with FOLFOX or XELOX regimens in advanced CRC. In
AGC, several retrospective studies revealed patients receiving 5-FU/leucovorin(LV),
capecitabine, or trastuzumab maintaining therapy experienced significantly longer PFS than
that stopped chemotherapy after first-line chemotherapy. Some one-arm phase II clinical
trials found 5-FU/LV, capecitabine, S-1, capecitabine plus bevacirumab, or capecitabine plus
bevacirumab plus trastuzumab maintenance seemed to yield sound PFS and good tolerance.
However, there were no randomized controlled clinical trials for maintenance treatment of
these regimens in AGC, except that a phase II Chinese randomized controlled trial of Uracil
and Tegafur (UFT) versus observation experienced early termination.
Above all, so far, there is no data to demonstrate that regular 2-6 months of chemotherapy
followed by maintenance treatment could prolong PFS and OS for AGC. S-1 is effective for
gastric cancer, and was approved as palliative treatment for advanced gastric cancer and
adjuvant treatment; in addition, with its relative less frequency of side effects and
convenient oral administration, S-1 as maintenance regimen could be prone to be accepted by
patients. Therefore, the current study is designed to investigate that S-1 as maintenance
treatment after first-line palliative chemotherapy could improve PFS and OS for patients with
advanced gastric cancer through a perspective randomized clinical study.