Rectal cancer Rectal cancer
Conditions
Interventions
Patient will receive treatment with the MAASTRO HDR rectal applicator as part of their standard rectal cancer treatment or as part of an interventional study treatment. In case of an interventional st
Sponsors
Maastro
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age = 18 years. - Histological proof of rectal cancer, or a strong suspicion after imaging. - Treatment with MAASTRO HDR rectal applicator - Informed consent for longitudinal observational data collection.
Exclusion criteria
Exclusion criteria: - Mentally incompetent patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.Duration of the application procedure.Clinical complete response rate up to 5 years after treatment.Rectal toxicity scored according to CTCAE v. 5 up to 3 years after treatment. Genitourinary toxicity scored according CTCAE v. 5 up to 3 years after treatment. Local recurrence rate up to 10 years after treatment. Locoregional recurrence rate up to 10 years after treatment.Metastatic rate up to 10 years after treatment.Salvage surgery rate after treatment.Overall and disease specific survival rate up to 10 year after treatmentDiscomfort/pain during endorectal irradiation using NRS painscore Separate informed consent will be asked for:Health status and quality of life as measured by QLQ-C30, QLQ-CR29 and EQ-5D up to 5 years after treatment.Long-term rectal functional outcome as measured by LARS score up to 5 years after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| nvt | — |
Countries
Netherlands
Contacts
Public ContactB Hupkens
Maastro
Outcome results
None listed