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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2023
  • participants needed
    60
  • sponsor
    Institut Cancerologie de l'Ouest
Updated on 7 October 2022
adenocarcinoma

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

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

Details
Condition Rectal Cancer
Treatment Empty Bladder planning CT scan and CBCTs
Clinical Study IdentifierNCT04323722
SponsorInstitut Cancerologie de l'Ouest
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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