Lymphocyte-sparing Thoracic Radiotherapy for Esophageal Squamous Cell Carcinoma
ConditionEsophageal Squamous Cell Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients are able to understand and are willing to participate in the trial, and a signed consent form can be obtained;
Pathologically confirmed esophageal squamous cell carcinoma;
locally advanced ESCC (cT3-4 or N+);
the age of patients should be more than 18 years, and less than 80 years;
Disqualifiers
diagnosis of metastatic esophageal cancer;
Patient refuses to receive systemic drug treatment;
clinical diagnosis of pleural metastasis or malignant pleural effusion;
Pregnant or breastfeeding women;
Trial design
Design model
Parallel
Treatments tested in this trial
lymphocyte-sparing radiotherapy
Radiationthe 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.
conventional radiotherapy
Radiationthe 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.
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: lymphocyte-sparing radiotherapyExperimental treatment 0 interventions
Group B: conventional radiotherapyActive comparator 0 interventions
Trial outcomes
Primary outcomes
1
acute grade 3/4 lymphopenia
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
Time frame
1 months after surgerySecondary outcomes
1
Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group
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
within 1 week after completion of neoadjuvat radiotherapy plan;2
Incidence of grade 3 or higher hematologic toxicity
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
from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy3
Pathological complete response rate (pCR)
The pCR rate in ESCC patients who underwent nCRT and radical surgery between lymphocyte-sparing RT group and conventional RT group.
Time frame
1 months after surgery4
R0 resection rate
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 surgerySponsors and contacts
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Source ClinicalTrials.gov