Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651697
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
BladdEr Full OR Empty for Pelvic Radiation Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BladdEr Full OR Empty for Pelvic Radiation Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEFORE
Brief Summary:
The present study evaluates empty and full bladder protocols for radiation therapy of genitourinary GU gynecological Gyn and gastrointestinal GI malignancies of the pelvis
Detailed Description:
Pelvic radiation therapy plays a key role in the treatment of common genitourinary GU gynecological Gyn and gastrointestinal GI malignancies of the pelvis Prior to starting a course of radiation therapy patients undergo a CT simulation that allows for computer-based optimization of radiation dose delivery to target while simultaneously minimizing dose to surrounding normal tissues such as the bladder and rectum Commonly physicians instruct patients undergoing pelvic radiation therapy to present with a reproducibly full bladder for the simulation and for each subsequent treatment session with the hope that increased distance between normal tissues anterior bladder wall and bowel and treatment target will limit toxicity However treating with a full bladder can result in wide variations in bladder volume Often patients are unable to reproduce the bladder distention achieved at simulation especially as typical urinary symptoms related to radiation develop during treatment As the initial CT simulation is used to calculate dose distribution bladder volume changes can affect radiation dose distribution to the bladder itself as well as adjacent pelvic organs Given the challenges and uncertainties of treating with a full bladder there has been increasing interest in bladder empty protocols Retrospective non-randomized single-institution studies demonstrate that bladder empty protocols reduced absolute variation in bladder volume during treatment had minimal impact on treatment related toxicity and had non-inferior biochemical progression free survival GI toxicities and GU toxicities However prospective data is very limited The present study plans to fill this knowledge gap by randomizing study participants to empty and full bladder protocols for simulation and radiation therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None