Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).
Eligibility criteria
Qualifiers
Pathology proven pancreatic ductal adenocarcinoma (PDAC);
At least two (preferably four) months systemic therapy with (m)FOLFIRINOX and/or gemcitabine + nab-paclitaxel; or eligibility for chemotherapy but no initiation of chemotherapy based on patients' wish;
No option for surgical resection, either because anatomical irresectability based on the surgeon's judgement (assessed on imaging or during explorative laparotomy) and/or frailty (unfit for surgery or chemotherapy) and/or no surgery based on patient's wish.
No evidence of distant metastatic disease progression, evaluated by CT Thorax / Abdomen / Pelvis and/or PET-CT scan;
Disqualifiers
Contra-indications for MRI or CT with an intravenous contrast agent according to the protocol of the local radiology and/or radiotherapy departments
Contraindications for MRgRT, as determined by the involved expert radiation oncologists of the Consortium
<18 years old
Pregnancy
Trial design
Treatments tested in this trial
- MR guided radiotherapy
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
UMC Utrecht
Lead sponsor
Amsterdam UMC, location VUmc
Collaborator
Radboud University Medical Center
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Centre for Human Drug Research, Netherlands
Collaborator
Dutch Pancreatic Cancer Group (DPCG)
Collaborator
Source ClinicalTrials.gov