DETECT: DEfining the Target volume for Endoluminal radiation boosting in patients with reCTal cancer
Recruiting
- Conditions
- rectal cancerrectal carcinoma1001799010017991
- Registration Number
- NL-OMON52208
- Lead Sponsor
- MAASTRO clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- >=18 years of age and capable of giving informed consent.
- ycT1-3N0 residual histology confirmed rectal adenocarcinoma after neoadjuvant
radiotherapy or long-course chemoradiotherapy for which patients will undergo
TME surgery.
- Minimal interval between end of neoadjuvant chemoradiotherapy or
radiotherapy: 6 weeks.
Exclusion Criteria
- Patient has received brachytherapy as part of neoadjuvant treatment.
- <18 years of age or incapable of giving informed consent.
- Patient has not been treated with neoadjuvant radiotherapy or long-course
chemoradiotherapy.
- Patient will not undergo TME surgery for a ycT1-3N0 residual histology
confirmed rectal adenocarcinoma.
- Interval between end of neoadjuvant therapy and surgery is <6 weeks.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maximum distance of microscopic tumor spread per patient in all directions:<br /><br>The maximum distance of microscopic tumor spread in all directions from the<br /><br>macroscopic remnant in the specimen will be measured per patient in millimeters<br /><br>using a standardized protocol by the pathology department.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Main secondary parameters/endpoints<br /><br>- Maximum distance of microscopic tumor spread per patient in all directions as<br /><br>seen by eye and/or on imaging (ultrasound, MRI):<br /><br>A tissue deformation factor/model and the location of the microscopic tumor<br /><br>spread in relation to the macroscopic remnant determined during pathological<br /><br>analysis, will be used to determine the maximum distance of microscopic tumor<br /><br>spread as seen by eye and/or on imaging (US, MRI) per patient in all directions<br /><br>in millimeters.<br /><br>- Treatment margin relative to the macroscopic tumor to cover 90% and 95% of<br /><br>MTS:<br /><br>90% and 95% of the maximum distance of MTS in all directions in millimeters<br /><br>including 95% confidence intervals, both reported including and excluding ypT0<br /><br>patients. Reported both by eye and on imaging, for which i.a. the tissue<br /><br>deformation model will be used.</p><br>