Status:
COMPLETED
Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Esophageal Carcinoma
Neoadjuvant Chemoradiotherapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival...
Eligibility Criteria
Inclusion
- Age:18-70 years
- Histologically verified squamous carcinoma of the thoracic esophagus.
- Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
- Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.
- Joined the study voluntarily and signed informed consent form
- No surgical contraindications
- No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN
Exclusion
- Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).
- Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.
- Invasion of the tracheobronchial tree or aorta
- Tracheoesophageal fistula
- Concurrent pregnancy or lactation
- Severe diabetes mellitus with poor blood glucose control
- History of a second malignancy
- Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.
- Patients undergoing esophageal reconstruction with jejunum.
- Patients have allergy reaction or contraindications to taxanes.
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2023
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03381651
Start Date
February 22 2018
End Date
February 22 2023
Last Update
November 18 2024
Active Locations (2)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China