Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection
Status:
Recruiting
Trial end date:
2026-01-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
The First Affiliated Hospital of Anhui Medical University