NCT06160557

A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma

A Single-arm, Prospective, Multi-center Phase II Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Xiaomeng Zheng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of observational study is to learn about the outcomes of the participants. The main questions it aims to answer are: 1. ESD additional postoperative radiotherapy in patients with non healing SESCC overall survival (OS) and disease-free survival (DFS) 2. The adverse events (AE) of additional radiotherapy after ESD for non-curative SESCC patients were counted, and its safety was evaluated. Participants will receive radiation therapy as necessary.

Detailed description

This study is an in ESD subjects, early postoperative esophageal cancer pathology returns have cut edge positive, lymphatic vascular invasion, SM2 - SM3 or pathologic stage under the condition of low degree of differentiation, observe additional radiation noninferiority and safety of single arm, multicenter, phase II clinical study. The test plan into the group of 40 cases of the subjects, the ESD additional postoperative radiotherapy group, using three dimensional conformal radiation therapy and intensity-modulated radiation therapy technology. Good ESD within 2 months, after the ulcer healing began RT as a supplementary treatment. All patients underwent CT simulation before treatment, and the location of the tumor bed was determined according to the lesion location under ultrasound gastroscopy before ESD and the scar tissue formed after ESD. If necessary, titanium clips were placed under gastroscopy before the first radiotherapy to locate the tumor bed, that is, GTVtb. CTV1 of cervical and middle and upper thoracic esophageal cancer included bilateral supraclavicular and mediastinal lymph nodes to the tracheal bifurcation area, the so-called "short T" field. CTV1 of lower thoracic esophageal cancer includes mediastinum, perigastric and lymphatic drainage areas above the celiac trunk. Plans to target (PTV) has CTV1 outside enlarge margins of 0.5 cm. The dose to PTV was 45Gy/25 fractions /5 weeks (5 days/week), and the dose to PGTVtb was 50Gy/25F(simultaneous boost). For patients with positive margins, the PTV dose was 48Gy/30 fractions /6 weeks (5 days/week), and the PGTVtb dose was 60Gy/30 fractions. The study was followed up for a total of 3 years. During the study period, the subjects were evaluated by tumor imaging before and after the additional radiotherapy. All participants were treated until disease progression, development of unacceptable toxicity, receipt of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, or other conditions judged by the investigator to warrant discontinuation of treatment.

Conditions

• Esophagus Cancer
• Radiotherapy
• Endoscopic Mucosal Resection

Timeline

• Start date: 2023-11-29
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-12-07
• Last updated: 2024-01-03

Locations

1 site across 1 country: China