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Esophageal Squamous Cell CarcinomaLEONCT05951127

Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

A study testing Esophagectomy in people with Esophageal Squamous Cell Carcinoma and Oligometastatic Disease, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

At present, there are relatively clear treatment guidelines for colorectal cancer with oligometastases, while the treatment mode for resectable esophageal cancer with oligometastases is not clear and there is a lack of research results in this field. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Esophagectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
2 sitesChina
Study dates
1 Nov 2022to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed ESCC, and stage was evaluated as cT1-4aN0-3 with oligometastases at initial treatment(According to UICC TNM version 8).
  • Oligonucleotides transfer is defined as: there are 3 or less than 3 lesions in single organ(lung, liver, brain or bone), and could be resected, radiofrequency ablation or radiotherapy in 1 radiation fied; Supraclavicular lymph node metastasis is defined as a distant metastases, celiac axis lymph nodes are considered as regional lymph nodes for the patients with lower 1/3 ESCC; Supraclavicular lymph nodes in patients with upper thoracic and cervical esophageal cancer were defined as regional lymph nodes, while abdominal trunk lymph nodes were considered as distant metastases；
  • No new metastatic lesions were found after more than 3 months of systemic treatment, and primary esophageal cancer lesions and regional lymph nodes can be resected R0;
  • No serious internal disease, KPS score ≥90;
  • The evaluation of various organ functions can tolerate surgery, radiotherapy and other treatments;
  • The following laboratory tests confirmed that bone marrow, liver and kidney function met the requirements for study participation: Hemoglobin ≥9.0g/L; White blood cell count ≥3.5×109/L; Neutrophil absolute value (ANC) ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; ALT and AST≤2 times the upper limit of normal value; The international standardized ratio of prothrombin time was less than 1.5 times the upper limit of normal value, and part of the thrombin time was within the normal range; Creatinine ≤1.5 times the upper limit of normal value;
  • Physical state ECOG 0-1;
  • Subject must understand and sign the informed consent form.

Who cannot join

  • Patients with double primary cancer;
  • mental patients;
  • Patients with parotid or salivary gland diseases;
  • Mediastinal lymph nodes could not be thoroughly dissected during radical resection of esophageal cancer; Or the oligometastatic lesions cannot receive local treatment due to location and other reasons;
  • Patients with severe emphysema and pulmonary fibrosis;
  • Active infections requiring medical treatment;
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  • Existing or co-existing hemorrhagic disease;
  • Other uncontrollable patients who cannot tolerate chemoradiotherapy or surgery;
  • Patients who cannot be thoroughly cleaned due to previous operations;
  • Pregnant or lactating female patients.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

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

    Beijing, 100021

Other trials in China

About this study

Official title: Additional Local Consolidative Esophagectomy to Traditional Systemic Therapy for Patients With Oligometastatic Resectable ESCC: A Multi-center, Open-label, Randomized Controlled Tial (LEO)

At present, there are relatively clear treatment guidelines for colorectal cancer with oligometastases, while the treatment mode for resectable esophageal cancer with oligometastases is not clear and there is a lack of research results in this field. The aim of this study is to provide evidence of the optimal therapy model for the local resectable esophageal cancer with oligometastases ESCC patients, by investigating whether 2-year OS of the patients could benefit from additional local consolidative esophagectomy.

Read the detailed description

This study was designed as a multicenter, open-label, randomized controlled prospective clinical study. The experimental group (group A) received additional esophagectomy after 3-month systemic treatment, and the control group (group B) received only systemic treatment. 2-year OS, 3-year PFS and OS were observed in the two groups.

Being tested
Esophagectomy
Keywords
Esophageal Squamous Cell Carcinoma, oligometastatic disease, Esophagectomy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • EsophagectomyProcedure or surgery

    Esophagectomy for esophageal cancer and regional lymph nodes dissection.

Study groups in NCT05951127
Study groupRoleWhat they receive
Additional Local Consolidative Esophagectomy GroupExperimentalThe patient in this arm will go on esophagectomy base on tracitional systemic therapy.
Receives: Procedure: Esophagectomy
Traditional Systemic Therapy GroupNo interventionThe patients in this arm will receive traditional therapy, including chemotherapy, immunotherapy, radiotherapy, ect.

What is being measured

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

  1. 2-year OS

    2-year overall survival

    Measured: Dead time from signing the consent form

Secondary outcomes (2)

  1. 3-year OS

    3-year overall survival

    Measured: Dead time from signing the consent form

  2. 3 years PFS

    Recurrence of new metastasis from singing the consent form

    Measured: Recurrence time from signing the consent form

Timeline

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

  1. First posted18 Jul 2023
  2. Study start1 Nov 2022
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951127
Sponsor's protocol ID
NCC3640
Acronym
LEO
Status last verified
Jul 2023
First submitted
18 Mar 2023
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Esophagectomy in people with Esophageal Squamous Cell Carcinoma and Oligometastatic Disease, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 18 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 2 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?

This study is still under way. Results are not available in the source record yet.

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?

2-year OS (time frame: Dead time from signing the consent form). 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 NCT05951127.

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 18 Jul 2023.

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