PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

NCT03244566 | Completed

• 1 other identifier: PETCLM
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 4

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 treatment in many countries for patients with esophageal cancer. To improve the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in 1980s. More potential positive lymph nodes were found during more extended lymphadenectomy, offering more accurate TNM staging, affecting consequent treatment. However，3-field-lymphadenectomy was associated with increased surgical morbidity and mortality. Positron emission tomography (PET) is used for detecting distant metastases and lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)

Conditions

Esophageal Cancer

Keywords

positron emission tomography; cervical lymphatic metastasis

Outcome Measures

Primary Outcomes (1)

• cervical lymph node metastasis

  postoperative pathological examination

  Decembear 2018

Secondary Outcomes (3)

• mediastinal and abdonimal lymph nodes metastasis

  Novermber 2018

• postoperative complications

  March 2019

• diseases-free survival

  November 2021

Interventions

positron emission tomography DIAGNOSTIC_TEST

patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients had resectable thoracic esophageal squamous cell carcinoma.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (4)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

Fujian Medical University Cancer Hospital

Fuzhou, Fujian, China

Location

Jiangdu people's hospital of Yangzhou

Yangzhou, Jiangsu, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Haiquan Chen, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 9, 2017
• Study Start: June 26, 2018
• Primary Completion: November 28, 2018
• Study Completion: July 1, 2021
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

CN (4)