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

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

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