Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that \~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected \>T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
768
Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGDisease-free/Relapse-free survival
The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.
Time frame: 5 years
Overall survival
The time interval from randomization to death from any cause or end of follow-up whichever occurs first.
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Time frame: 2 years
Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30
Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.
Time frame: 5 years
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