Status:
ACTIVE_NOT_RECRUITING
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Lead Sponsor:
Fudan University
Conditions:
Esophagus Cancer
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04764227
Start Date
May 30 2020
End Date
March 30 2027
Last Update
August 3 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032