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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Empty Bladder planning CT scan and CBCTs
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rectal Cancer focused on measuring 3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de Cacerologie de l'ouest - site Paul PapinRecruiting
  • ICO René GauducheauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Empty bladder

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 23, 2020
Last Updated
August 29, 2022
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT04323722
Brief Title
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
Acronym
MESORECT-VV
Official Title
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric, open prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empty bladder
Arm Type
Experimental
Arm Description
Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with filling bladder
Intervention Type
Procedure
Intervention Name(s)
Empty Bladder planning CT scan and CBCTs
Intervention Description
Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder
Primary Outcome Measure Information:
Title
Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
Description
Throughout the radiotherapy treatment, the reproducibility of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder
Time Frame
3.5 years
Title
Evaluate using imaging techniques and dosimetric analysis the performance of empty versus filled bladder radiotherapy treatment
Description
Throughout the radiotherapy treatment, the reliability of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Evaluate mesorectal movements during radiotherapy in empty versus filled bladder
Description
Compare mesorectal movements during radiotherapy treatment compared to the planning CT scan in the case of a filled versus an empty bladder
Time Frame
3.5 years
Title
Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder
Description
Compare changes in bladder volume during treatment versus planning CT scan for filled bladder versus empty bladder
Time Frame
3.5 years
Title
IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or empty bladder
Description
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
Time Frame
3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel RIO, MD
Phone
+33240679900
Email
emmanuel.rio@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia ALLAM, PhD
Phone
+33240679826
Email
nadia.allam@ico.unicancer.fr
Facility Information:
Facility Name
Institut de Cacerologie de l'ouest - site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amaury Paumier, MD
Phone
+33241352700
Email
Amaury.Paumier@ico.unicancer.fr
Facility Name
ICO René Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel RIO, MD
Phone
+33240679900
Email
emmanuel.rio@ico.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

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