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Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy

ConditionLocally Advanced Pancreatic Adenocarcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MR guided radiotherapy

    Radiation

    5 fractions of 10 Gray MRgRT in addition to standard of care

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

HRQoL deterioration-free survival

HRQoL deterioration-free survival is defined as the Time Until Definitive Deterioration (TUDD) including death from any cause, calculated from the time of randomization. HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary Score.

Time frame
Through study completion, an average of 18 months

Secondary outcomes

1

Overall survival

The time interval between LAPC diagnosis and either death from any cause or last follow-up

Time frame
From the date of LAPC diagnosis untill either death from any cause or last follow-up, whichever came first, assessed up to 18 months
2

Patient reported Quality of Life EORTC QLQ-PAN26

Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-PAN26

Time frame
At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
3

Patient reported Quality of Life EORTC QLQ-C30

Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-C30

Time frame
At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
4

Patient reported Quality of Life EQ5D-5L

Part of the Patient Reported Outcome Measures (PROMs) using EQ5D-5L

Time frame
At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: