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NCT Number: NCT06360653

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

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ARNAS Civico Hospital, Palermo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Stereotactic Post-operative Radiotherapy for Endometrial Cancer

Radiation

Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.

Primary outcomes

  1. Acute G3 or higher Gastrointestinal and Genitourinary Toxicity

    Time frame: 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 outcomes

  1. Late Gastrointestinal and Genitourinary Toxicity

    Time frame: 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

  2. Distant Progression Free Survival

    Time frame: 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

  3. Local Control

    Time frame: 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

  4. Overall Survival

    Time frame: From enrollment to a follow-up time of 5 years

    The rate of death events in the cohort of patients enrolled

  5. Overall Quality of Life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

FRANCESCO CUCCIA, MD

CONTACT

[email protected]

+393334393336

GIUSEPPE FERRERA, MD

CONTACT

[email protected]

+393471533715

Sponsors and collaborators

Lead sponsor

ARNAS Civico Di Cristina Benfratelli Hospital

Other

Collaborators

  • Accuray Incorporated

Registry information

Official study title

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

Acronym: SISTER-RAY

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 11, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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