PET in Guiding Cervical Lymphadenectomy (ECTOP-2003) (PETCLMESCC)

The Utility of Positron Emission Tomography (PET) in Predicting Cervical Lymphatic Metastasis for Mid-lower Thoracic Esophageal Squamous Cell Carcinoma

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)

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Diagnostic test: positron emission tomography

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-field lymphadenectomy. Lymph nodes will be recored according to the anatomy site. Lymph nodes metastasis diagnosed by PET/CT and by postoperation pathological examination will be compared to evaluate the role of PET/CT in guiding the extent of lymphadenecomy and surgical approach.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Beijing
    • Beijing, Beijing, China, 100021
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Cancer Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • Jiangdu people's hospital of Yangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients had resectable thoracic esophageal squamous cell carcinoma.

Description

Inclusion Criteria:

1. Histologically proven esophageal cancer
2. Resectable cT1-T3/N0-N1 thoracic，operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, and barium swallow
3. Karnofsky performance status greater than or equal to 80%
4. Acceptable pulmonary and cardiac function.
5. Acceptable hepatic, renal and bone marrow function

Exclusion Criteria:

1. Low performance status(Karnofsky score <80%)
2. Past history of malignancy
3. Unresectable advanced disease(T4 or M1a,M1b)
4. Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
5. Medically unfit for surgical resection
6. Pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
7. A significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
8. Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
9. Significant psychiatric illness that would interfere with patient compliance
10. Severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
11. Salvage surgery after definitive chemoradiotherapy
12. Patients have neoadjuvant chemoradiotherapy
13. Above the age of 80 years
14. Unreliable for follow up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical lymph node metastasis	postoperative pathological examination	Decembear 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mediastinal and abdonimal lymph nodes metastasis	postoperative pathological examination	Novermber 2018
postoperative complications	surgical morbidity and mortality	March 2019
diseases-free survival	from the time of surgery to the time of first recurrence or death	November 2021

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Haiquan Chen, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: August 6, 2017
• First Submitted That Met QC Criteria: August 6, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: positron emission tomography; cervical lymphatic metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: PETCLM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No