Comparing capecitabine treatment to observation for certain gastric cancer patients after surgery
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial
This study is testing if the chemotherapy drug capecitabine can help certain gastric cancer patients live longer after their surgery compared to just being monitored.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 768 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Anhui Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT03817268 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of capecitabine, a chemotherapy drug, compared to observation in patients with specific stages of gastric adenocarcinoma who have undergone R0 resection. The study focuses on patients with stage pT1N+M0 or pT2-3N0M0 gastric cancer, where the benefit of adjuvant chemotherapy remains uncertain according to existing guidelines. By enrolling patients shortly after surgery, the trial aims to determine if capecitabine can improve survival outcomes in this population. The trial is designed as a Phase 3 interventional study to provide robust evidence on the treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with microscopically confirmed gastric adenocarcinoma at specific stages who have undergone radical surgery.
Not a fit: Patients with distant metastasis, serious comorbidities, or those who have received other cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the use of capecitabine as a beneficial adjuvant therapy for patients with early-stage gastric cancer.
How similar studies have performed: While there is limited randomized data on this specific patient population, similar studies have explored adjuvant chemotherapy in gastric cancer with varying results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.