a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer

Not Applicable

Not yet recruiting

• Conditions: Endometrial Cancer
• Interventions: Radiation: Stereotactic Post-operative Radiotherapy for Endometrial Cancer

• Registration Number: NCT06360653
• Lead Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital

Brief Summary

The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer

Detailed Description

Endometrial cancer represents the sixth global female cancer, and adjuvant radiotherapy has a main role in the management of these patients.

This treatment usually covers the surgical bed, the upper portion of the vagina and the pelvic lymph nodes. In the last decades, the technological progress has allowed clinicians to offer a more accurate planning and delivery of the treatment with modern IMRT-IGRT techniques.

Nonetheless, radiotherapy regimens were still based on 25-30 fractions schedules. More recently, similarly to other oncological settings like prostate, breast or rectal cancer, 5-fractions schedules have been considered as potentially useful also in this setting.

On this purpose, this study aims to investigate the feasibility of a shorter adjuvant radiotherapy treatment for endometrial cancer, by assessing acute and late toxicity, quality of life and clinical outcomes.

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Start: 2024-09
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Prior pelvic radiotherapy
• Para-aortic lymph nodes involvement
• ECOG PS ≥ 3
• Any diagnosis of inflammatory bowel disease (both active or quiescent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Stereotactic Post-operative Radiotherapy for Endometrial Cancer	Patients with endometrial cancer (stage IB-IIIC1) with histological and molecular features that require adjuvant external beam radiotherapy alone or in combination with chemotherapy and/or brachytherapy. Adjuvant radiotherapy will be performed with stereotactic body radiotherapy schedule of 30 Gy in 5 sessions.

Primary Outcome Measures

Name	Time	Method
Acute G3 or higher Gastrointestinal and Genitourinary Toxicity	From the end of treatment to a time interval of 12 weeks	The number of any G3 or higher adverse event occurring within 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Distant Progression Free Survival	From enrollment to a follow-up time of 5 years	The rate of distant failure of the disease in all the participants enrolled for adjuvant SBRT
Overall Survival	From enrollment to a follow-up time of 5 years	The rate of death events in the cohort of patients enrolled
Late Gastrointestinal and Genitourinary Toxicity	From enrollment to a follow-up time of 5 years	The number of any G3 or higher adverse event occurring after 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria
Local Control	From enrollment to a follow-up time of 5 years	The rate of local failure of the disease in all the participants enrolled for adjuvant SBRT
Overall Quality of Life	From enrollment to a follow-up time of 5 years	The mean values of Quality of life questionnaires performed at baseline and at 3-6-12-18-24-36- 48-60 months from the end of treatment, with the QLQ-C30 and QLQ-EN24 fulfilled by all patients enrolled

Trial Locations

Locations (1)

ARNAS Civico Hospital; 🇮🇹 Palermo, PA, Italy