Rectal Cancer
Conditions
Keywords
Ultrasound elastography, Rectal cancer, Preoperative chemoradiation
Brief summary
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score. The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.
Interventions
Non-invasive
Sponsors
Vejle Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge. 2. T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR \< 5 mm. 3. Life expectancy of more than 3 months. 4. Age ≥18 years. 5. Performance status ≤ 2 according to WHO. 6. Patient able to observe protocol guidelines. 7. Signed informed consent.
Exclusion criteria
1. Previous radiation treatment for the pelvis. 2. Known distant metastases. 3. Serious disease contraindicating treatment, including cardiovascular disease. 4. Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri. 5. Pacemaker 6. other disease making the patient unfit for study participation as assessed by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor regression grade | 8 weeks after operation |
Countries
Denmark
Outcome results
None listed