Trials / Recruiting
RecruitingNCT01917552
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 870 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
multi-center, prospective, randomized, open-label phase III
Detailed description
This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB (by AJCC 6th edition) gastric cancer with at least one additional risk factor (additional risk factors for recurrence include age \>65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capecitabine | capecitabine 1250 milligram (mg) / m² po bid (D1-14) |
Timeline
- Start date
- 2013-08-19
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2013-08-06
- Last updated
- 2024-02-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01917552. Inclusion in this directory is not an endorsement.