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

NCT04323722 | Completed Results

• 1 other identifier: ICO-2019-15
• Study Type: interventional
• Target: 53
• 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 (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.

  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.

  5 weeks

Secondary Outcomes (2)

• Differences in Bladder Volumes During Treatment (CBCTs) Compared to pCT

  5 weeks

• Safety Margins to Cover 95% of the Patient Population

  5 weeks

Study Arms (1)

Empty and full bladder

OTHER

pCT and CBCTs in empty and full bladder conditions

Procedure: Empty Bladder pCT and CBCTs; Procedure: Full Bladder pCT and CBCTs

Interventions

Empty Bladder pCT and CBCTs PROCEDURE

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

Empty and full bladder

Full Bladder pCT and CBCTs PROCEDURE

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

Empty and full 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

Results Point of Contact

• Title: Dr Emmanuel RIO
• Organization: Institut de Cancérologie de l'Ouest (ICO)

emmanuel.rio@ico.unicancer.fr

+33 2 40 67 99 00

Study Officials

• Emmanuel RIO, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: June 23, 2026
• Results First Posted: June 23, 2026

Record last verified: 2024-11

Locations

FR (2)