Rectal Cancer
Conditions
Keywords
3D conformal radiotherapy (3DCRT), Intensity-modulated radiotherapy (IMRT), bladder filling, mesorectal movements, filled bladder, empty bladder, cone-beam computerized tomography (CBCT)
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
Detailed description
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
Interventions
PROCEDUREEmpty Bladder pCT and CBCTs
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
PROCEDUREFull Bladder pCT and CBCTs
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
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Monocentric, open prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between the Mesorectal Anterior Distance Measured on the pCT and the Distance Measured on Each CBCT, at Different Heights Set on Bone Landmarks. | 5 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Bladder Volumes During Treatment (CBCTs) Compared to pCT | 5 weeks | Differences in bladder volume measured on CBCT during treatment were compared with bladder volumes on planning CT (pCT) acquired with empty and full bladder. |
| Safety Margins to Cover 95% of the Patient Population | 5 weeks | 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% |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREmmanuel RIO, MD
Institut de Cancérologie de l'Ouest
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment France | 48 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
None listed