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

• Conditions: Esophageal Cancer

• Registration Number: NCT05460403
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-04-23
• Status Verified: 2022-07
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-13
• Last Update Submitted: 2022-07-13
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Primary Completion: 2023-07-02
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3591

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 5 years	From the date of surgery to the date of death or the most recent follow-up.

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	up to 5 years	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.
Local-regional recurrence-free survival (LRFS)	up to 5 years	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.
Distant metastasis (DM)	up to 5 years	From the date of surgery to the date of metastasis in distant lymph nodes, distant organs or the most recent follow-up.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, Chaoyang, China