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Esophageal CancerNCT03244566

PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

An observational study of Esophageal Cancer, run by Fudan University at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Esophageal Cancer
What is being tested?
positron emission tomography
How many people
110 participants
Where
4 sitesChina
Study dates
26 Jun 2018to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients had resectable thoracic esophageal squamous cell carcinoma.

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

China4 sites

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

    Beijing, Beijing Municipality, 100021

  • Fujian Medical University Cancer Hospital

    Fuzhou, Fujian

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Jiangdu people's hospital of Yangzhou

    Yangzhou, Jiangsu

Other trials in China

About this study

Official title: 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)

Read the 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.

Keywords
positron emission tomography, cervical lymphatic metastasis
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • positron emission tomographyDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cervical lymph node metastasis

    postoperative pathological examination

    Measured: Decembear 2018

Secondary outcomes (3)

  1. mediastinal and abdonimal lymph nodes metastasis

    postoperative pathological examination

    Measured: Novermber 2018

  2. postoperative complications

    surgical morbidity and mortality

    Measured: March 2019

  3. diseases-free survival

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

    Measured: November 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start26 Jun 2018
  3. Primary completion28 Nov 2018
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244566
Sponsor's protocol ID
PETCLM
Status last verified
Jul 2023
First submitted
6 Aug 2017
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by Fudan University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cervical lymph node metastasis (time frame: Decembear 2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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