Clinical trial · Interventional
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- S-1
- interventionNames
- Drug: S-1
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Up to 2 years
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven gastric or gastroesophageal junction adenocarcinoma * Metastatic or recurrent unresectable disease * Measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) * Age: 65-85 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl) * Adequate renal function (serum creatinine≤ 1.5) * Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal \[UNL\], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL) * No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient Exclusion Criteria: * Previous palliative chemotherapy * Known allergy to study drugs * CNS metastasis * Significant medical comorbidities * Active ongoing infection which antibiotic treatment is needed. * Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.
References
Publications (0)
Data not yet available