Stereotactic Post-operative Radiotherapy for Endometrial Cancer
RadiationPatients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.
NCT Number: NCT06360653
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
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Not applicable
ARNAS Civico Hospital, Palermo, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.
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
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
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
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
Time frame: From enrollment to a follow-up time of 5 years
The rate of death events in the cohort of patients enrolled
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
Contact information is provided by the study sponsor or research team.
FRANCESCO CUCCIA, MD
CONTACT
GIUSEPPE FERRERA, MD
CONTACT
ARNAS Civico Di Cristina Benfratelli Hospital
Other
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
Acronym: SISTER-RAY
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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