PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT03244566
• Lead Sponsor: Fudan University

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)

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 Timeline

• Study First Submitted: 2017-08-06
• Study First Submitted QC: 2017-08-06
• Study First Posted: 2017-08-09
• Study Start: 2018-06-26
• Primary Completion: 2018-11-28
• Study Completion: 2021-07-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cervical lymph node metastasis	Decembear 2018	postoperative pathological examination

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Fujian Medical University Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China

Jiangdu people's hospital of Yangzhou; 🇨🇳 Yangzhou, Jiangsu, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China