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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Empty Bladder planning CT scan and CBCTs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, open prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empty bladder<br>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<br>* Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)