Esophageal Squamous Cell Cancer
Conditions
Keywords
esophageal cancer, neoadjuvant treatment, lymphocyte-sparing radiotherapy, prognosis
Brief 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.
Interventions
RADIATIONlymphocyte-sparing radiotherapy
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.
RADIATIONconventional radiotherapy
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.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are able to understand and are willing to participate in the trial, and a signed consent form can be obtained; 2. Pathologically confirmed esophageal squamous cell carcinoma; 3. locally advanced ESCC (cT3-4 or N+); 4. the age of patients should be more than 18 years, and less than 80 years; 5. aged between 18 and 80 years; 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute grade 3/4 lymphopenia | 1 months after surgery | from treatment to 1 months after completion of neoadjuvant chemoradiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 3 or higher hematologic toxicity | 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. |
| Pathological complete response rate (pCR) | 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. |
| R0 resection rate | 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. |
| Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group | 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) |
| recurrence-free survival | 2 year | from completion of surgery to any recurrence |
| Overall survival | 3 years | from treatment to death |
| Postoperative complications | 1 month after surgery | which was defined as 30-day postoperative complications graded according to the Clavien-Dindo classification; |
Countries
China
Contacts
CONTACTWei-Xiang Qi, Dr.
Outcome results
None listed