Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer (NCT04323722) | Clinical Trial Compass
CompletedNot Applicable
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer
France53 participantsStarted 2020-09-08
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.