Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

Study Overview
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Brief Summary
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This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Detailed Description
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Surgery is one of the most important curative approaches for esophageal cancer. In real-world clinical practice, over 50% of the patients receiving surgical resection as primary management. For patients treated with surgical resection without adjuvant therapy, the probability of local-regional recurrence ranged from 23.0% to 56.5%, accounting for 55.6%-84.5% of the disease recurrence. Once encountering disease recurrence, the subsequent prognosis could be dismal. The median survival time after postoperative disease recurrence ranged from 3 to 8 months. Postoperative radiotherapy (PORT) was one of the potential topical treatment approaches prolonging local-regional recurrence time or moreover, attaining superior disease-free survival (DFS) or overall survival (OS) in selected patients. It is essential to identify patients potentially benefit from PORT. Besides, there were few studies evaluating the impact of postoperative radiation dose to survival outcomes in patients receiving PORT. Whether the PORT-related local-regional recurrence free survival (LRFS) enhancement could convert to OS or DFS improvement is still vague. The current study aimed at evaluating the value of PORT in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

Official Title
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Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Radiation: Adjuvant Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: KPS≥70 Pathologically diagnosis of esophageal cancer Complete resection (R0 resection) Exclusion Criteria: Diagnosed with other malignancy within 5 years before surgery Encountered recurrence or port-site implantation receiving palliative-intended radiotherapy Diagnosed with adenosquamous carcinoma or basal cell-like carcinoma Treated with PORT with uncertain radiation dose Treated with PORT with radiation dose > 60Gy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery alone<br>patients without adjuvant radiotherapy after R0 resection. | |
| Adjuvant Radiotherapy<br>patients treated with adjuvant radiotherapy after R0 resection. | Radiation: Adjuvant Radiotherapy<br>* Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | From the date of surgery to the date of death or the most recent follow-up. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | From the date of surgery to the date of any evidence of disease recurrence (recurrence in the tumor bed, anastomotic orifice, or in the regional lymph nodes, or metastasis in distant lymph nodes or distant organs), death or the most recent follow-up. | up to 5 years | 
| Local-regional recurrence-free survival (LRFS) | From the date of surgery to the date of recurrence in the tumor bed, anastomotic orifice, regional lymph nodes or the most recent follow-up. | up to 5 years | 
| Distant metastasis (DM) | From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up. | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, postoperative radiotherapy, adjuvant radiotherapy