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Trial Title:
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
NCT ID:
NCT06360653
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
endometrial cancer
radiotherapy
sbrt
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Post-operative Radiotherapy for Endometrial Cancer
Description:
Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter
schedule of 30 Gy in 5 sessions.
Arm group label:
Experimental arm
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.
Criteria for eligibility:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ARNAS Civico Hospital
Address:
City:
Palermo
Zip:
90100
Country:
Italy
Contact:
Last name:
FRANCESCO CUCCIA, MD
Phone:
+393334393336
Email:
francesco.cuccia@arnascivico.it
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
ARNAS Civico Di Cristina Benfratelli Hospital
Agency class:
Other
Collaborator:
Agency:
Accuray Incorporated
Agency class:
Industry
Source:
ARNAS Civico Di Cristina Benfratelli Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06360653
