Clinical trial · Interventional
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
NCT02867839CI-TRIAL-00083201RESCUE-GCterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The number of patients enrolled was much less than expected
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Oxaliplatin plus S-1 | Drug | — | UNRESOLVED |
| S-1 only | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: postoperative Oxaliplatin plus S-1
- description
- Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later. Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40\~60mg bid, po, d1\~14, q3W (6 months)
- interventionNames
- Drug: Oxaliplatin plus S-1
- type
- ACTIVE_COMPARATOR
- label
- B: postoperative S-1 only
- description
- Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later. S-1: 40\~60mg bid, po, d1\~14, q3W (12 months)
- interventionNames
- Drug: S-1 only
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * sign written informed consent form * age ≥ 18 years, ≤69 years * ECOG status: 0\~2 * pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version) * negative peritoneal cytology * underwent curative distal gastrectomy with D2 lymph node dissection * no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy * adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN. Exclusion Criteria: * be enrolled in other clinical trials * underwent prior antitumor treatment * allergic reaction to S-1 or oxaliplatin * abnormal GI tract function * female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy * other situation to be judged not adaptive to the study by investigators
References
Publications (1)
- DERIVEDHu X, Chen L, Du Y, Fan B, Bu Z, Wang X, Ye Y, Zhang Z, Xiao G, Li F, He Q, Li G, Shen X, Xiong B, Zhu L, Liu J, Liu L, Wu T, Zhou J, Zhang J, Zhao G, Wang X, Liang P, Wang X, Zhang Y, Wu X, Zhang J, Ji X, Zong X, Fu T, Jia Z, Ji J. Postoperative chemotherapy with S-1 plus oxaliplatin versus S-1 alone in locally advanced gastric cancer (RESCUE-GC study): a protocol for a phase III randomized controlled trial. Chin J Cancer Res. 2017 Apr;29(2):144-148. doi: 10.21147/j.issn.1000-9604.2017.02.07. PMID 28536493