Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05951127
• Other study ID #: NCC3640
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2027

Study information

• Verified date: July 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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;

3. No serious internal disease, KPS score =90;

4. The evaluation of various organ functions can tolerate surgery, radiotherapy and other treatments;

5. 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;

6. Physical state ECOG 0-1;

7. Subject must understand and sign the informed consent form.

Exclusion Criteria

1. Patients with double primary cancer;

2. mental patients;

3. Patients with parotid or salivary gland diseases;

4. 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;

5. Patients with severe emphysema and pulmonary fibrosis;

6. Active infections requiring medical treatment;

7. Existing or co-existing hemorrhagic disease;

8. Other uncontrollable patients who cannot tolerate chemoradiotherapy or surgery;

9. Patients who cannot be thoroughly cleaned due to previous operations;

10. Pregnant or lactating female patients.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Oligometastatic Disease

Intervention

Procedure:
• Esophagectomy
Esophagectomy for esophageal cancer and regional lymph nodes dissection.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year OS	2-year overall survival	Dead time from signing the consent form
Secondary	3-year OS	3-year overall survival	Dead time from signing the consent form
Secondary	3 years PFS	Recurrence of new metastasis from singing the consent form	Recurrence time from signing the consent form