Precisely Estimation of the Prognostic Value of Lymph Node in ESCC

NCT04764240 | Completed

• 1 other identifier: ASJSTO1901
• Study Type: observational
• Target: 3,700
• Locations: 0 countries
• Sites: N/A

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. The datasets were approved for research by the institutional review board of each participating center. Prior to surgery, all patients received computerised tomography (CT) of the chest and abdomen and EUS as part of their routine staging workup. Patients received whole body FDG-PET to eliminate the possibility of distant metastases if the attending physician considered it was necessary. All patients in the dataset received a surgical R0 resection; patients who received an R1 or R2 resection were excluded. Notably, there is nothing approaching a consensus on the extent of lymph node dissection for ESCC patients. Patients who received neoadjuvant therapy were excluded due to the influence of neoadjuvant therapy on lymph node status and pathologic T stage. The primary endpoints were overall survival (OS), which was defined as the time between surgical resection and death from any cause, and cancer-specific survival (CSS), defined as the time from surgical resection to death caused by ESCC. After receiving esophagectomy, patients were followed up by clinical examination every three months for the first year, every three to six months for the second year, and every six to twelve months from then on.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  Five years

Interventions

R0 resection with lymphadenectomy PROCEDURE

Patients received a surgical R0 resection; patients who received an R1 or R2 resection were excluded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients elder than 18 years old received computerised tomography (CT) of the chest and abdomen and EUS as part of their routine staging workup. Patients received whole body FDG-PET to eliminate the possibility of distant metastases if the attending physician considered it was necessary. Patients underwent R0 resection and lymphadenectomy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Cancer Hospital, China: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2003
• Primary Completion: December 30, 2013
• Study Completion: December 1, 2018
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share