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

NCT04323722 | Completed

• 1 other identifier: ICO-2019-15
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Rectal Cancer

Keywords

3D conformal radiotherapy (3DCRT); Intensity-modulated radiotherapy (IMRT); bladder filling; mesorectal movements; filled bladder; empty bladder; cone-beam computerized tomography (CBCT)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Evaluate mesorectal movements during radiotherapy in empty versus filled bladder

  3.5 years

• Evaluate changes in bladder volume during radiotherapy in empty versus filled bladder

  3.5 years

• IMRT (Intensity-Modulated Radiotherapy) dosimetric study in patients with filled or empty bladder

  3.5 years

Study Arms (1)

Empty bladder

EXPERIMENTAL

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

Interventions

Empty Bladder planning CT scan and CBCTs PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (2)

Institut de Cacerologie de l'ouest - site Paul Papin

Angers, 49055, France

Location

ICO René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, open prospective study

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: September 8, 2020
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

FR (2)