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Trial Title:
Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06596954
Condition:
Esophageal Squamous Cell Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Squamous Cell
Conditions: Keywords:
esophageal cancer
neoadjuvant treatment
lymphocyte-sparing radiotherapy
prognosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
lymphocyte-sparing radiotherapy
Description:
the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% coverage of the PTV (Planning Target
Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the
required dose constraints. While maintaining target coverage and traditional OAR (Organs
At Risk) dose constraints, also address dose for lymphocyte-relate organs including the
TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.
Arm group label:
lymphocyte-sparing radiotherapy
Intervention type:
Radiation
Intervention name:
conventional radiotherapy
Description:
the radiotherapy regimen is 41.4Gy/23Fx. Ensure 95% coverage of the PTV (Planning Target
Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the
required dose constraints. do not limit dose for lymphocyte-relate organs including the
TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels.
Arm group label:
conventional radiotherapy
Summary:
Esophageal squamous cell carcinoma (ESCC) is one of the most aggressive malignant tumors.
Although neoadjuvant chemoradiotherapy combined with surgery has significantly improved
the survival rate of patients with locally advanced esophageal cancer, approximately half
of the patients will experience local regional recurrence or distant metastasis.
Lymphocytes are crucial immune cells in the human body, playing a key role in combating
infections and tumor development. In recent years, an increasing body of research has
indicated that lymphocyte depletion is a significant factor associated with poor
prognosis in various solid tumors, including esophageal cancer. The lymphocyte depletion
caused by radiotherapy has garnered considerable attention from oncologists. However,
there is still a lack of prospective clinical research data on lymphocyte protection in
thoracic tumors. Therefore, this study aims to provide high-level evidence from
evidence-based medicine regarding the correlation between lymphocyte depletion and
prognosis in esophageal cancer patients, offering more effective strategies and methods
to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. patients approve and sign written informed consent;
2. Pathologically confirmed esophageal squamous cell carcinoma;
3. the age of patients should be more than 18 years, and less than 80 years;
4. KPS score of patients should be more than 80
Exclusion Criteria:
1. diagnosis of metastatic esophageal cancer;
2. Patient refuses to receive systemic drug treatment;
3. clinical diagnosis of pleural metastasis or malignant pleural effusion;
4. Pregnant or breastfeeding women;
5. Severe non-cancerous medical comorbidities that affect the implementation of
radiotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin hospital, Shanghai jiaotong university school of medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei-Xiang Qi, Dr.
Phone:
02164370045
Email:
qwx12055@rjh.com.cn
Contact backup:
Last name:
shengguang zhao, Dr.
Start date:
June 30, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06596954
