Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with filling bladder

Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder

Empty Bladder planning CT scan and CBCTs

Emmanuel RIO, MD

Nadia ALLAM, PhD

Amaury Paumier, MD

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 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

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

Throughout the radiotherapy treatment, the reproducibility of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder

Throughout the radiotherapy treatment, the reliability of positioning of the anterior surface of mesorectum will be assessed with empty and filled bladder

Compare mesorectal movements during radiotherapy treatment compared to the planning CT scan in the case of a filled versus an empty bladder

Compare changes in bladder volume during treatment versus planning CT scan for filled bladder versus 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

Institut Cancerologie de l'Ouest

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Conventional drinking protocol - 200ml water prior to treatment.

Empty bladder

Full bladder

Alison Birtle

Radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. Tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. It is not uncommon for some men to have "accidents" during treatment causing understandable distress. This can also extend the treatment time and cause knock on delays in the radiotherapy department.

Several United Kingdom (UK) centres report treating with an empty bladder. The investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.

50 patients receiving radical radiotherapy to the prostate were randomised using closed envelope technique 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for International prostate Symptom Score(IPSS), Late Effects Normal Tissue Task Force - Subjective, Objective, Management, Analytic (LENT SOMA) bowel toxicity and quality of life questionnaires. The investigators also looked at bowel and bladder Dose Volume Histogram (DVH) to ensure constraints were met.

50 patients receiving radical radiotherapy to the prostate were randomised using 1:1 into 2 groups. Group A followed the conventional drinking protocol at our centre (200ml prior to treatment) and group B were treated with an empty bladder. Baseline, end of treatment and 6 week follow up scores were prospectively collected for IPSS, LENT SOMA bowel toxicity and quality of life questionnaires.

Investigator masking for randomisation purposes only. Masking not possible for intervention whilst on treatment.

Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.

IPSS - The International Prostate Symptom Score is a 7 question scale which assesses urinary toxicity. Each question is scored 0-5 totalling a maximum score of 35. A score of 0-7 correlates to mildly symptomatic; 8-19, moderately symptomatic; 20-35, severely symptomatic.

LENT SOMA - The Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales. This is a questionnaire that assesses individual bowel symptoms asking initially whether or not they occur and then scoring the frequency, the higher the score, the more frequent the event. Each question has it's own range of score which is explained on the questionnaire. The scores will be compared for individual questions and there will not be any combining of scores between questions.

Dose to bowel and bladder is calculated and documented if it meets the optimal or mandatory constraints

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest
Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.	NCT03832803	Prostate Cancer Radiotherapy Si...	Empty bladder Full bladder	18 Years -	Lancashire Teaching Hospitals NHS Foundation Trust
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest
Less to Hold - A Comparison of Bladder Toxicities (Side Effects) in Patients Undergoing Prostate Radiotherapy Between Patients Treated With Empty Bladder and Those on a Drinking Protocol.	NCT03832803	Prostate Cancer Radiotherapy Si...	Empty bladder Full bladder	18 Years -	Lancashire Teaching Hospitals NHS Foundation Trust
Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	NCT04323722	Rectal Cancer	Empty Bladder p...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for empty bladder