pancreatic cancer pancreatic cancer
Conditions
Interventions
Five fractions of 8 Gy radiotherapy
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients suspect for localized (non-metastasized) PDAC preferably pathology proven and otherwise based on consensus by a multidisciplinary team (see section 4.1 for explanation). Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50-70; WHO 2) or patients who choose to refrain from surgery or chemotherapy)NB: In case treatment with chemotherapy is stopped, i.e. due to intolerability, a patient may be included in the study if no more than two cycles were administered. The interval between the last cycle of chemotherapy and the first fraction of radiation therapy should be at least six weeks. Additionally, in the case patient suffered from side effects of the chemotherapy these have to score < 1 (CTCAE v.5.0) prior to start of radiation therapy. Written informed consent
Exclusion criteria
Exclusion criteria: Age <18 yearsDistant metastasisImminent bowel obstructionActive bleedingUncontrolled infectionIf more than two cycles of chemotherapy were administered prior to inclusion.Contra-indications for MRI (only for VUmc and UMCU)pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants. Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metalPatients with severe claustrophobia not able to tolerate an MRI scanPatients with a non-MR-compatible (hip/knee/jaw) prosthesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at six months, measured from the time of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life assessment using EORTC quality of life questionnaires (QLQ-C30, EORTC-PAN26) at baseline, 3-6-12- monthsCa19.9, at baseline, 3-6-12 monthsToxicity will be scored using CTCAE v 5.0 criteria, at baseline, last fraction, 3 and 6 weeks, 3-6-12 monthsNRS pain score: at baseline, 3-6-12 monthsWHO performance: at baseline 3-6-12 monthsImaging after 3-6-12 months | — |
Countries
Netherlands
Contacts
Public ContactAME Bruynzeel
Amsterdam UMC
Outcome results
None listed