prostate cancer rectal cancer
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients have to be older than 18 years. * They have to be diagnosed with prostate or rectal cancer and willing to undergo a treatment with radiotherapy with curative intent at the AMC.
Exclusion criteria
Exclusion criteria: * Incapacitated patients. * Any 3T MRI contra-indications stated by the AMC MRI safety committee (see appendix A) * Patients with one or two hip prosthesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In each of the 29 prostate cancer patients, a registration of fiducials will be made for each of the 35 treatment fractions. In each of the 29 rectal cancer patients, a registration based on bony anatomy will be made and the best fitting plan will be selected from the LOP for each of the 25 fractions. Each registration consists of a vector in x-, y-, and z-direction. These will be noted and the standard deviation of all the registration vectors per patient will be calculated. We will refer to this parameter as the variation in registrations per patient. In case a patient is not able to complete his treatment, he/she will be replaced by another patient. We will perform a noninferiority test (* = 0.05, 1-* = 0.80) on both the variation of the registrations on fiducials in prostate patients and the variation of the registrations based on bony anatomy in rectal patients. The null hypothesis is that the standard deviation of the variation in the MR-only workflow is higher and thus inferior to the conventional workflow. We expect a common standard deviation of 0.8 mm for the registration on fiducials in prostate cancer patients. We expect a common standard deviation of 0.55 mm for the registration based on bony anatomy in rectum cancer patients. We reject the null hypothesis at a limit difference of 2/3 of the expected standard deviation, thus 0.53 mm in the prostate cancer patients and 0.37 mm in the rectal cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameter is the feasibility of the plan selection for the rectal cancer patients. This evaluation is qualitative. The plan selected per fraction in the MR-only workflow should be the same as in the conventional workflow. Also, the RTT should experience this as equally difficult. This will be qualified by the RTT*s from the research team as they perform the simulated MR-only workflow. These RTT*s have extended clinical experience in plan selection. They will report parameters such as time needed and certainty in decision making. | — |
Countries
Netherlands
Outcome results
None listed