Status:
COMPLETED
PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)
Lead Sponsor:
Fudan University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-80 years
Brief Summary
Esophageal cancer is the eighth most common cancer around the world, with more than 450000 new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is the mainstay of t...
Detailed Description
From June, 2018, a total of 110 patients with thoracic esophageal carcinoma will be recruited in 4 hospital in China. Participants with resectable esophageal cancer will have PET/CT scan before three-...
Eligibility Criteria
Inclusion
- Histologically proven esophageal cancer
- Resectable cT1-T3/N0-N1 thoracic，operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, and barium swallow
- Karnofsky performance status greater than or equal to 80%
- Acceptable pulmonary and cardiac function.
- Acceptable hepatic, renal and bone marrow function
Exclusion
- Low performance status(Karnofsky score \<80%)
- Past history of malignancy
- Unresectable advanced disease(T4 or M1a,M1b)
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Medically unfit for surgical resection
- Pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- A significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
- Significant psychiatric illness that would interfere with patient compliance
- Severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
- Salvage surgery after definitive chemoradiotherapy
- Patients have neoadjuvant chemoradiotherapy
- Above the age of 80 years
- Unreliable for follow up
Key Trial Info
Start Date :
June 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03244566
Start Date
June 26 2018
End Date
July 1 2021
Last Update
July 13 2023
Active Locations (4)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
2
Fujian Medical University Cancer Hospital
Fuzhou, Fujian, China
3
Jiangdu people's hospital of Yangzhou
Yangzhou, Jiangsu, China
4
Fudan University Shanghai Cancer Center
Shanghai, China