Endometrial Cancer
Conditions
Keywords
endometrial cancer, radiotherapy, sbrt
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.
Interventions
RADIATIONStereotactic Post-operative Radiotherapy for Endometrial Cancer
Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.
Sponsors
Accuray Incorporated
ARNAS Civico Di Cristina Benfratelli Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 Survival | From enrollment to a follow-up time of 5 years | The rate of death events in the cohort of patients enrolled |
| 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 |
Countries
Italy
Contacts
Primary ContactFRANCESCO CUCCIA, MD
Backup ContactGIUSEPPE FERRERA, MD
Outcome results
None listed