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Trial Title:
Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC
NCT ID:
NCT05951127
Condition:
Esophageal Squamous Cell Carcinoma
Oligometastatic Disease
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
Esophageal Squamous Cell Carcinoma
oligometastatic disease
Esophagectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Esophagectomy
Description:
Esophagectomy for esophageal cancer and regional lymph nodes dissection.
Arm group label:
Additional Local Consolidative Esophagectomy Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
November 1, 2022
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05951127
