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Completed

NCT Number: NCT03244566

PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

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)

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. cervical lymph node metastasis

    Time frame: Decembear 2018

    postoperative pathological examination

Secondary outcomes

  1. mediastinal and abdonimal lymph nodes metastasis

    Time frame: Novermber 2018

    postoperative pathological examination

  2. postoperative complications

    Time frame: March 2019

    surgical morbidity and mortality

  3. diseases-free survival

    Time frame: November 2021

    from the time of surgery to the time of first recurrence or death

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Aug 9, 2017
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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