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

Institut Cancerologie de l'Ouest53 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

Empty Bladder pCT and CBCTsPROCEDURE

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Institut de Cacerologie de l'ouest - site Paul Papin

Angers, France

ICO René Gauducheau

Saint-Herblain, France

Outcomes

Primary Outcomes

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.

Time frame: 5 weeks

Secondary Outcomes

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.

Time frame: 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%

Time frame: 5 weeks

Data from ClinicalTrials.gov

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