Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Recruiting
Phase 3
Interventional Study
Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 74
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 870 (estimated)
- Sponsor
- Asan Medical Center · Other
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About This Trial
multi-center, prospective, randomized, open-label phase III
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Curatively resected gastric or gastroesophageal junction adenocarcinoma
* Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor for recurrence (additional risk factors for recurrence include age \>65 years, male gender, presence of lymphovascular i…
Contacts