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

Rectal Cancer Clinical Trial

— MESORECT-VV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323722
• Other study ID #: ICO-2019-15
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Institut Cancerologie de l'Ouest
• Contact: Emmanuel RIO, MD
• Phone: +33240679900
• Email: emmanuel.rio[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cacerologie de l'ouest - site Paul Papin	Angers
France	ICO René Gauducheau	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment	Throughout the radiotherapy treatment, the reproducibility of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder	3.5 years
Primary	Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment	Throughout the radiotherapy treatment, the reliability of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder	3.5 years
Secondary	Evaluate mesorectal movements during radiotherapy in empty versus filled bladder	Compare mesorectal movements during radiotherapy treatment compared to the planning CT scan in the case of a filled versus an empty bladder	3.5 years
Secondary	Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder	Compare changes in bladder volume during treatment versus planning CT scan for filled bladder versus empty bladder	3.5 years
Secondary	IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or 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	3.5 years