NCT05869123

Online Adaptive Radiotherapy for Postoperative Treatment of Endometrial and Cervical Cancer

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical with Reduced Margin

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.

Detailed description

This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).

Conditions

• Uterine Cervical Neoplasm
• Endometrial Neoplasms

Interventions

Type	Name	Description
RADIATION	Online adaptive radiotherapy	PTV with 5 margins covers CTV

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-03-03
• Completion: 2025-03-03
• First posted: 2023-05-22
• Last updated: 2024-11-21

Locations

1 site across 1 country: China