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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empty and full bladder | Other | pCT and CBCTs in empty and full bladder conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 weeks |
| Safety Margins to Cover 95% of the Patient Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel RIO, MD | Institut de Cancérologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cacerologie de l'ouest - site Paul Papin | Angers | 49055 | France | |||
| ICO René Gauducheau |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empty and Full Bladder | Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with full bladder Empty Bladder planning CT scan and CBCTs: Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Empty Bladder | Planning CT scan and CBCTs with empty bladder after standard Planning CT scan and CBCTs with full bladder Empty Bladder planning CT scan and CBCTs: Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results are presented in terms of group systematic error and standard deviation of the systematic error. | Posted | Mean | Standard Deviation | mm | 5 weeks |
|
Adverse and serious adverse events are followed during 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empty and Full Bladder | pCT and CBCTs in empty and full bladder conditions Empty and full Bladder pCT and CBCTs: Patient will receive a pCT, 3 CBCTs on the first week and once a week during radiotherapy treatment in empty and full bladder conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emmanuel RIO | Institut de Cancérologie de l'Ouest (ICO) | +33 2 40 67 99 00 | emmanuel.rio@ico.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2023 | Mar 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Monocentric, open prospective study
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| 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 |
|
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% |
| 5 weeks |
| Saint-Herblain |
| 44805 |
| France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | cm3 | 5 weeks |
|
|
|
| Secondary | 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% | Posted | Number | mm | 5 weeks |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| Anterior segment safety margin under full bladder conditions |
|
| Middle segment safety margin under full bladder conditions |
|
| Lower segment safety margin under full bladder conditions |
|