Clinical trial · Interventional
A Phase II Study of Postoperative S-1-Based Chemoradiotherapy in Gastric Cancer
A Phase II Trial of Intensity-Modulated Radiotherapy Combined With S-1 Based Chemotherapy in Completely Resected Gastric Cancer
- 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)
The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy, Adjuvant | — | UNRESOLVED | — |
| Radiotherapy, Intensity-Modulated | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity-modulated radiotherapy | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 based chemoradiotherapy
- description
- S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner.
- interventionNames
- Radiation: intensity-modulated radiotherapy
- Drug: S-1
Primary outcomes (4)
- measure
- Disease free survival
- timeFrame
- 3 years
- measure
- Locoregional recurrence free survival
- timeFrame
- 3 years
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection * Any prior chemotherapy is allowed in this protocol * No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation * No prior abdominal or pelvic radiotherapy * Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months * Patients must have normal organ and marrow function as defined below: * Leukocytes greater than or equal to 3,000 G/L * Platelets: greater than or equal to 100,000/mm3 * Hemoglobin:greater than or equal to 10g/L * Total bilirubin: within normal institutional limits * AST/ALT: less than or equal to 1.5 times the upper limit * Creatinine within normal upper limits * Informed consent Exclusion Criteria: * Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation * History of allergic reactions attributed to similar chemical or biologic complex to S-1 * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * History of prior radiation to the abdomen * Pregnant or lactating females
References
Publications (0)
Data not yet available