Clinical trial · Interventional
Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
NCT01831531CI-TRIAL-00037125completedPhase 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 trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1
- description
- Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy
- interventionNames
- Drug: S-1
- Radiation: Radiation therapy
Primary outcomes (2)
- measure
- Number of participants with adverse events
- timeFrame
- 1 years
- measure
- 3-yr local control rate
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form; * Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy * Both genders * Esophageal squamous cell carcinoma confirmed by pathology * Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th) * No radiotherapy, chemotherapy or other treatments prior to enrollment * PS ECOG 0-2 * Life expectancy of more than 3 months * Hemoglobin（Hb）≥9 g/dL * WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L * platelet count (Pt) ≥100x 109/L * Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN * Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency * Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: * Complete esophageal obstruction * Deep esophageal ulcer * Esophageal perforation * Haematemesis * After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * Participation in other interventional clinical trials within 30 days * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Drug addiction * Alcoholism or AIDS * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * Patient who has metastasis such as lung, liver metastasis
References
Publications (1)
- DERIVEDChen Y, Zhu Z, Zhao W, Liu Q, Zhang J, Deng J, Ai D, Lu S, Jiang L, Tseng I, Jia H, Zhao K. Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities. Front Oncol. 2022 Apr 5;12:839765. doi: 10.3389/fonc.2022.839765. eCollection 2022. PMID 35449578