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Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC (LEO)

Primary Purpose

Esophageal Squamous Cell Carcinoma, Oligometastatic Disease

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esophagectomy
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal Squamous Cell Carcinoma, oligometastatic disease, Esophagectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria 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; 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Additional Local Consolidative Esophagectomy Group

Traditional Systemic Therapy Group

Arm Description

The patient in this arm will go on esophagectomy base on tracitional systemic therapy.

The patients in this arm will receive traditional therapy, including chemotherapy, immunotherapy, radiotherapy, ect.

Outcomes

Primary Outcome Measures

2-year OS
2-year overall survival

Secondary Outcome Measures

3-year OS
3-year overall survival
3 years PFS
Recurrence of new metastasis from singing the consent form

Full Information

First Posted
March 18, 2023
Last Updated
July 11, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05951127
Brief Title
Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC
Acronym
LEO
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2027 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Oligometastatic Disease
Keywords
Esophageal Squamous Cell Carcinoma, oligometastatic disease, Esophagectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional Local Consolidative Esophagectomy Group
Arm Type
Experimental
Arm Description
The patient in this arm will go on esophagectomy base on tracitional systemic therapy.
Arm Title
Traditional Systemic Therapy Group
Arm Type
No Intervention
Arm Description
The patients in this arm will receive traditional therapy, including chemotherapy, immunotherapy, radiotherapy, ect.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Esophagectomy for esophageal cancer and regional lymph nodes dissection.
Primary Outcome Measure Information:
Title
2-year OS
Description
2-year overall survival
Time Frame
Dead time from signing the consent form
Secondary Outcome Measure Information:
Title
3-year OS
Description
3-year overall survival
Time Frame
Dead time from signing the consent form
Title
3 years PFS
Description
Recurrence of new metastasis from singing the consent form
Time Frame
Recurrence time from signing the consent form

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Li, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

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Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

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