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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Radiation: Adjuvant Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05460403

K201427

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,591 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,591 participants in 2 patient groups

Surgery alone

Description:

patients without adjuvant radiotherapy after R0 resection.

Adjuvant Radiotherapy

Description:

patients treated with adjuvant radiotherapy after R0 resection.

Treatment:

Radiation: Adjuvant Radiotherapy