Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

• Status: Recruiting
• Trial end date: 2027-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Joined the study voluntarily and signed informed consent form;

• Age 18-75;

• ECOG 0-2;

• Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;

• The operative incision healed well;

• T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);

• No radiotherapy, chemotherapy or other treatments pre (post) surgery;

• PS ECOG 0-2;

• Life expectancy of more than 3 months;

• Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 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 after surgery, Esophageal perforation, Haematemesis;

• 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;

• Unsuitable to be enrolled in the trial in the opinion of the investigators.