Rectal CancerMESORECT-VVNCT04323722
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
A study testing Empty Bladder pCT and CBCTs and Full Bladder pCT and CBCTs in people with Rectal Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Empty Bladder pCT and CBCTs and Full Bladder pCT and CBCTs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Sep 2020to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cacerologie de l'ouest - site Paul Papin
Angers, 49055
ICO René Gauducheau
Saint-Herblain, 44805
About this study
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
Read the 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 (pCT) with filled bladder and then with empty bladder on the same day. Only pCT with filled bladder will be used patient treatment.
During radiotherapy treatment, patient will receive Cone beam CT (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 pCT) 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
- Conditions
- Rectal Cancer
- Being tested
- Empty Bladder pCT and CBCTs, Full Bladder pCT and CBCTs
- Keywords
- 3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empty Bladder pCT and CBCTsProcedure or surgery
Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment in an Empty Bladder conditions
Full Bladder pCT and CBCTsProcedure or surgery
Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment in a full Bladder conditions
| Study group | Role | What they receive |
|---|---|---|
| Empty and full bladder | Other | pCT and CBCTs in empty and full bladder conditions Receives: Procedure: Empty Bladder pCT and CBCTs; Procedure: Full Bladder pCT and CBCTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the Mesorectal Anterior Distance Measured on the pCT and the Distance Measured on Each CBCT, at Different Heights Set on Bone Landmarks.
The mesorectal anterior distance was measured on planning pCT and on each CBCT at predefined heights based on bone landmarks. Differences between pCT and CBCT measurements were assessed.
Measured: 5 weeks
Secondary outcomes (2)
Differences in Bladder Volumes During Treatment (CBCTs) Compared to pCT
Differences in bladder volume measured on CBCT during treatment were compared with bladder volumes on planning CT (pCT) acquired with empty and full bladder.
Measured: 5 weeks
Safety Margins to Cover 95% of the Patient Population
Gaussian distribution models were generated for each predefined anatomical level, under both full-bladder and empty-bladder conditions, to identify the anterior safety margin required to achieve population coverage probabilities of 95%
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start8 Sep 2020
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, open prospective study
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel RIO, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323722
- Sponsor's protocol ID
- ICO-2019-15
- Acronym
- MESORECT-VV
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2020
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04323722
- Acronym / sponsor ID
- MESORECT-VV / ICO-2019-15
- Conditions
- Rectal Cancer
- Keywords
- 3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (pCT) with filled bladder and then with empty bladder on the same day. Only pCT with filled bladder will be used patient treatment.
During radiotherapy treatment, patient will receive Cone beam CT (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 pCT) 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, open prospective study
| Arm | Type | Receives |
|---|---|---|
| Empty and full bladder | Other | Procedure: Empty Bladder pCT and CBCTs, Procedure: Full Bladder pCT and CBCTspCT and CBCTs in empty and full bladder conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empty Bladder pCT and CBCTsPatient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment in an Empty Bladder conditions | Procedure or surgery | Empty and full bladder |
| Full Bladder pCT and CBCTsPatient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment in a full Bladder conditions | Procedure or surgery | Empty and full bladder |
Primary outcome
Difference Between the Mesorectal Anterior Distance Measured on the pCT and the Distance Measured on Each CBCT, at Different Heights Set on Bone Landmarks.
Time frame: 5 weeks
The mesorectal anterior distance was measured on planning pCT and on each CBCT at predefined heights based on bone landmarks. Differences between pCT and CBCT measurements were assessed.
2 secondary outcomes
Differences in Bladder Volumes During Treatment (CBCTs) Compared to pCT
Time frame: 5 weeks
Safety Margins to Cover 95% of the Patient Population
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel RIO, MD principal investigator
Institut de Cancérologie de l'Ouest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empty Bladder pCT and CBCTs and Full Bladder pCT and CBCTs in people with Rectal Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between the Mesorectal Anterior Distance Measured on the pCT and the Distance Measured on Each CBCT, at Different Heights Set on Bone Landmarks. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.