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Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with filling bladder

Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder

Empty Bladder planning CT scan and CBCTs

Emmanuel RIO, MD

Nadia ALLAM, PhD

Amaury Paumier, MD

This trial is assessing how Bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer

The purpose of this study is to show that the variations of bladder volume and mesorectal movements are less with empty versus filled bladder in rectal cancer.

In this study, patient will be treated with 3D conformal radiotherapy (3D-CRT) radiotherapy with a filled bladder condition, as per standard care, in supine position. A total dose of 45 or 50 Gy in 25 fractions, 5 fractions per week is received.

A Chest, abdomen and pelvis imaging will be performed before treatment start. Patients receive planning CT scan with filled bladder and then with empty bladder on the same day. Only planning CT scan with filled bladder will be used patient treatment.

During radiotherapy treatment, patient will receive CBCTs with filled ans empty bladder on Day 1 ; 2 and 3 on the first week and once a week after.

Multiple parameters will be assessed before treatment (using planning CT scan) and during radiotherapy treatment (CBCTs) in empty ans filled bladder conditions : Bladder volume, mesorectal movements.

A dosimetric study will be performed in Intensity-modulated radiotherapy (IMRT) in empty and filled bladder conditions

Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer

Throughout the radiotherapy treatment, the reproducibility of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder

Throughout the radiotherapy treatment, the reliability of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder

Compare mesorectal movements during radiotherapy treatment compared to the planning CT scan in the case of a filled versus an empty bladder

Compare changes in bladder volume during treatment versus planning CT scan for filled bladder versus empty bladder

Compare and validate (in silico on planning CT scan) the compliance with dose constraints to organs-at-risk in patients with filled or empty bladder in IMRT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for bladder filling