PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

NCT ID: NCT03244566

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2021-07-01

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.

Conditions

Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

positron emission tomography

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haiquan Chen

Chief,department of thoracic surgery, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiquan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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

Beijing, Beijing Municipality, China

Fujian Medical University Cancer Hospital

Fuzhou, Fujian, China

Jiangdu people's hospital of Yangzhou

Yangzhou, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, , China

Countries

China

Other Identifiers

PETCLM

Identifier Type: -

Identifier Source: org_study_id