Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer (MESORECT-VV)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Empty Bladder planning CT scan and CBCTs

Study type: Interventional

Funder types: Other

Identifiers

NCT04323722

ICO-2019-15

Details and patient eligibility

About

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

Full 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

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Empty bladder

Experimental group

Description:

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

Treatment:

Procedure: Empty Bladder planning CT scan and CBCTs