Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360653
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-05
Brief Title:
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
Sponsor:
ARNAS Civico Di Cristina Benfratelli Hospital
Organization:
ARNAS Civico Di Cristina Benfratelli Hospital
Study Overview
Official Title:
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer SISTER-RAY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SISTER-RAY
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None