Status:
RECRUITING
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection
Lead Sponsor:
The First Affiliated Hospital of Anhui Medical University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 metastasi...
Eligibility Criteria
Inclusion
- 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 μmol/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
- 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.
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
768 Patients enrolled
Trial Details
Trial ID
NCT03817268
Start Date
January 16 2019
End Date
January 30 2026
Last Update
April 20 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022