Clinical trial NCT04323722: Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
Official title: Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: 3D conformal radiotherapy (3DCRT)
Intensity-modulated radiotherapy (IMRT)
bladder filling
mesorectal movements
filled bladder
empty bladder
cone-beam computerized tomography (CBCT)
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, open prospective study
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma
* T2 N+ or T3 any N, eligible for radiotherapy or neo-adjuvant radio-chemotherapy treatment in a long course of 25 fractions
* Performance Status less or equal to 2
* Male or female 18 Years and older
* Creatinine clearance greater than or equal to 50ml/min
* Fertile patients must use effective contraception
* Written informed consent
* Patient must be affiliated to a Social Health Insurance

Exclusion Criteria:

* Previous treatment with pelvic radiotherapy
* Chronic inflammatory bowel disease in flare-up.
* Urinary catheterization, urinary diversion or cystectomy
* Hip prosthesis
* History of prostatectomy, or hysterectomy
* Urinary incontinence \> 2
* Pregnant or nursing patient
* Persons deprived of their liberty, as well as adults subject to a legal protection measure
* Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Primary outcomes:
measure: Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
timeFrame: 3.5 years
measure: Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
timeFrame: 3.5 years
Secondary outcomes:
measure: Evaluate mesorectal movements during radiotherapy in empty versus filled bladder
timeFrame: 3.5 years
measure: Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder
timeFrame: 3.5 years
measure: IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or empty bladder
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cacerologie de l'ouest - site Paul Papin
city: Saint-Herblain
country: France
facility: ICO René Gauducheau
Study officials:
References: