PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244566
• Other study ID #: PETCLM
• Status: Completed
• Start date: June 26, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2021
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Lymphatic Metastasis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cervical lymph node metastasis	postoperative pathological examination	Decembear 2018
Secondary	mediastinal and abdonimal lymph nodes metastasis	postoperative pathological examination	Novermber 2018
Secondary	postoperative complications	surgical morbidity and mortality	March 2019
Secondary	diseases-free survival	from the time of surgery to the time of first recurrence or death	November 2021