Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: S-1
* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1<br>Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy | Drug: S-1<br>* S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28<br>Radiation: Radiation therapy<br>* A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 1 years | 
| 3-yr local control rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years |