Clinical trial · Interventional
Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer
NCT01106066CI-TRIAL-00010715terminatedPhase 1 / Phase 2ClinicalTrials.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): Difficulties in recruiting patients
Summary
Brief summary (as posted)
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin | — | UNRESOLVED | — |
| Phase I: To Determine the Maximum Tolerated Dose (MTD) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, S-1, radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1/oxaliplatin/RT
- description
- Radiotherapy + 4 dose levels of oxaliplatin/S-1
- interventionNames
- Drug: Oxaliplatin, S-1, radiotherapy
Primary outcomes (1)
- measure
- MTD/pathologic CR
- timeFrame
- at the time of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients older than 18 years
* Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)
* ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form
Exclusion Criteria:
* T1 (regardless of N stage), T2N0
* M1 ③ Peritoneal seeding ④ Uncontrolled medical conditionReferences
Publications (0)
Data not yet available
No reference posted for this study.