Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, China, 200025
Location status: Recruiting
NCT Number: NCT06596954
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Shanghai, China, 200025
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 1 months after surgery
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
Time frame: within 1 week after completion of neoadjuvat radiotherapy plan;
the pass rate of the esophageal cancer lymphocyte-sparing plan is evaluated without compromising target volume coverage and conventional normal tissue constraints (heart, lungs, and spinal cord)
Time frame: from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy
The incidence of grade 3 or higher hematologic toxicity during nCRT and within 1 month after treatment between lymphocyte-sparing RT group and conventional RT group.
Time frame: 1 months after surgery
The pCR rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
Time frame: 1 month after surgery
the R0 resection rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
Time frame: 1 month after surgery
which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification;
Time frame: 2 year
from completion of surgery to any recurrence
Time frame: 3 years
from treatment to death
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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