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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916511
Other study ID # ESO-Shanghai9
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2016
Est. completion date July 1, 2023

Study information

Verified date December 2023
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 1, 2023
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
Carboplatin
carboplatin AUC=2, ivgtt, d1, qw*5
Radiation:
Radiotherapy
1.8Gy/d, d1-5/week, 25Fx

Locations

Country Name City State
China Fudan Universtiy Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Local control rate 2 years
Secondary overall survival 5 years
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