Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

NCT05951127 | Active Not Recruiting DMC

• 1 other identifier: NCC3640
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Squamous Cell Carcinoma; Oligometastatic Disease

Keywords

Esophageal Squamous Cell Carcinoma; oligometastatic disease; Esophagectomy

Outcome Measures

Primary Outcomes (1)

• 2-year OS

  2-year overall survival

  Dead time from signing the consent form

Secondary Outcomes (2)

• 3-year OS

  Dead time from signing the consent form

• 3 years PFS

  Recurrence time from signing the consent form

Study Arms (2)

Additional Local Consolidative Esophagectomy Group

EXPERIMENTAL

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

Procedure: Esophagectomy

Traditional Systemic Therapy Group

NO INTERVENTION

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

Interventions

Esophagectomy PROCEDURE

Esophagectomy for esophageal cancer and regional lymph nodes dissection.

Additional Local Consolidative Esophagectomy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

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

Beijing, 100021, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yin Li, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (2)