Trials / Terminated
TerminatedNCT02867839
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer
A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Peking University Cancer Hospital & Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
Detailed description
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxaliplatin plus S-1 | 8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1 |
| DRUG | S-1 only | 16 cycles of adjuvant chemotherapy with S-1 only |
Timeline
- Start date
- 2017-04-24
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2016-08-16
- Last updated
- 2024-12-03
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02867839. Inclusion in this directory is not an endorsement.