a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)

ARNAS Civico Di Cristina Benfratelli Hospital

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Radiation: Stereotactic Post-operative Radiotherapy for Endometrial Cancer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06360653

76CIVICO2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Age 18-80 years
• ECOG PS ≤ 2 or KPS ≥ 70%
• Patients diagnosed with endometrial cancer (endometrioid, serous cell, clear cell, carcinosarcoma) FIGO stage IB-IIIC1 candidate to post-operative external beam radiotherapy, based on molecular and histological findings
• Indications for chemotherapy and/or brachytherapy are not exclusion criteria for the purpose of the study
• Written Informed Consent

Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Radiation: Stereotactic Post-operative Radiotherapy for Endometrial Cancer