Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection

  • End date
    Jan 30, 2026
  • participants needed
  • sponsor
    The First Affiliated Hospital of Anhui Medical University
Updated on 24 January 2021
platelet count
gastric adenocarcinoma
neutrophil count
adjuvant therapy
cancer chemotherapy


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.

Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine monotherapy
Clinical Study IdentifierNCT03817268
SponsorThe First Affiliated Hospital of Anhui Medical University
Last Modified on24 January 2021


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Inclusion Criteria

Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction)
Cancer stage pT1N+M0 or pT2-3N0M0
Radical R0 resection
Retrieved lymph node number 15
Without hepatic, peritoneal, or other distant metastasis
Aged 18-70 years
No other cancer-directed therapy except primary cancer resection
Good tissue and organ function: white blood cell count 4000/mm3; neutrophil count 1500/mm3; platelet count 100000/mm3; total bilirubin 25.7 mol/L or within 1.5 times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate >60 mL/min
No serious cardiovascular or cerebrovascular disease
No concomitant or previous malignancies
Enrolled within 6 weeks after resection
Eastern Cooperative Oncology Group (ECOG) score 2
Clavien-Dindo morbidity score 0-2
Patient informed consent

Exclusion Criteria

The need to take phenytoin or coumarin anti-coagulates
Allergic to capecitabine or fluorouracil
Known DPD activity deficiency (DPYD gene mutation)
Pregnant or breeding women
All others contradictory to the items listed in the Inclusion Criteria
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