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Completed

NCT Number: NCT04323722

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

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

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cacerologie de l'ouest - site Paul Papin, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empty Bladder pCT and CBCTs

Procedure

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 CBCTs

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Differences in Bladder Volumes During Treatment (CBCTs) Compared to pCT

    Time frame: 5 weeks

    Differences in bladder volume measured on CBCT during treatment were compared with bladder volumes on planning CT (pCT) acquired with empty and full bladder.

  2. Safety Margins to Cover 95% of the Patient Population

    Time frame: 5 weeks

    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%

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: MESORECT-VV

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2020
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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