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

March 11, 2024 updated by: Institut Cancerologie de l'Ouest
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49055
        • Recruiting
        • Institut de Cacerologie de l'ouest - site Paul Papin
        • Contact:
      • Saint-Herblain, France, 44805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empty bladder
Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with filling bladder
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
Time Frame: 3.5 years
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
Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
Time Frame: 3.5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate mesorectal movements during radiotherapy in empty versus filled bladder
Time Frame: 3.5 years
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
Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder
Time Frame: 3.5 years
Compare changes in bladder volume during treatment versus planning CT scan for filled bladder versus empty bladder
3.5 years
IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or empty bladder
Time Frame: 3.5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2019-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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