Clinical trial · Interventional
Postoperative Chemoradiotherapy With S-1 in Gastric Cancer
A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
NCT01824004CI-TRIAL-00009884completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1,chemoradiotherapy, adjuvant treatment
- description
- Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given.
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Histologically proven gastric adenocarcinoma which is complete resected * ECOG performance status of 1 or lower * Adequate bone marrow function * absolute neutrophil count \[ANC\] ≥1,500µL, and platelets ≥100,000/µL * Adequate kidney function (serum creatinine \< 1.5 mg/dL) * Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL) serum transaminases levels \<2 times UNL * No prior chemotherapy Exclusion Criteria: * Other tumor type than adenocarcinoma * Evidence of distant metastasis * Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri * Uncontrolled infection * Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry * History of significant neurologic or psychiatric disorders including dementia or seizures * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study * Symptoms of gastrointestinal obstruction * concomitant drug medication: The following drugs cause drug interaction with S-1.
References
Publications (0)
Data not yet available
No reference posted for this study.