Overview

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.