ESO-Shanghai9

ESO-Shanghai9

The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.

2016-09-01

2021-07-01

2023-07-01

Completed

Early phase I

70

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

2023-12-22