Status:
COMPLETED
Precisely Estimation of the Prognostic Value of Lymph Node in ESCC
Lead Sponsor:
Shanghai Cancer Hospital, China
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Data were collected on a large multi-institution dataset consisting of ESCC patients who underwent surgery between January 2003 and December 2013 at ten institutions in the People's Republic of China....
Eligibility Criteria
Inclusion
- Minimum age: 18 years
- Patients underwent R0 resection and lymphadenectomy.
- ECOG PS less than or equal 2
- Adequate bone marrow function: Leukocytes \> 3,5 x 10\^9/L Absolute neutrophil count \> 1,5 x 10\^9/L Platelet count \> 100 x 10\^9/L Hemoglobin \> 10 g/dl
- Adequate hepatic function: Total bilirubin \< 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT \< 3 x ULN 7. Serum creatinine \< 1,5 mg/dl, creatinine-clearance \> 50 ml/min
- Written informed consent before randomization
Exclusion
- R1 or R2 resection
- Patients underwent neoadjuvant therapy
- Fertile patients without adequate contraception during therapy
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:\* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; \* active uncontrolled intercurrent infections or sepsis
- Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
3700 Patients enrolled
Trial Details
Trial ID
NCT04764240
Start Date
January 1 2003
End Date
December 1 2018
Last Update
February 23 2021
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