Trial Title:
Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy
NCT ID:
NCT06272162
Condition:
Locally Advanced Pancreatic Adenocarcinoma
Conditions: Keywords:
MR guided radiation therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
RCT
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
MR guided radiotherapy
Description:
5 fractions of 10 Gray MRgRT in addition to standard of care
Arm group label:
Intervention arm
Summary:
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).
Detailed description:
Rationale: About 40% of patients with pancreatic cancer are diagnosed with locally
advanced pancreatic cancer (LAPC). Recommended treatment consists of chemotherapy to
prevent disease dissemination and prolong survival. Nevertheless, local tumor growth
often causes severe morbidity, including pain, gastrointestinal obstruction, and
malnutrition. This has a substantial negative impact on health-related quality of life
(HRQoL). Eventually, one-third of patients die due to local tumor growth rather than from
systemic disease spread. For palliation of symptoms and improved local tumor control,
potentially prolonging survival, minimally-invasive ablative therapies may be effective.
Online adaptive stereotactic Magnetic Resonance-guided radiotherapy (MRgRT) is an
innovative treatment modality that enables high-precision ablative radiotherapy for
pancreatic tumors. This potentially improves RT efficacy without increasing the risk of
RT-related toxicity. Consequently, MRgRT holds promise for the treatment of pancreatic
cancer.
Objective: To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free
survival, including death as an event, in patients with LAPC after systemic chemotherapy.
Study design: Nationwide randomized controlled trial (1:1 randomization).
Study population: Patients with LAPC according to Dutch Pancreatic Cancer Group (DPCG)
criteria who are not eligible for tumor resection after at least two months of
chemotherapy (sample size 150 patients). Also, patients with LAPC who are eligible but
choose to refrain from chemotherapy and/or surgery can participate in this trial.
Intervention: Patients in the intervention arm receive 50Gy MRgRT in five fractions over
two weeks in one of the four Consortium Centers, followed by standard care, either
consisting of continuation of chemotherapy or best supportive care. Patients in the
control arm continue standard care without ablative MRgRT.
Main study endpoints: The primary outcome is HRQoL deterioration-free survival from the
time of randomization, defined as the Time Until Definitive Deterioration (TUDD)
including death as an event. HRQoL is evaluated using the EORTC QLQ-C30 Summary Score.
The TUDD is defined as a 10-point minimal clinically important difference compared to
baseline, with no further improvement of ≥10 points afterwards. All patients will be
offered home monitoring using the Trial@home platform to decrease the burden of trial
participation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
- Performance status WHO 0-2.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catharina Hospital
Address:
City:
Eindhoven
Zip:
5623 EJ
Country:
Netherlands
Contact:
Last name:
J. C.M. Scheepens, MD
Email:
j.c.m.scheepens-7@umcutrecht.nl
Investigator:
Last name:
H. M.U. Peulen, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Amsterdam University Medical Center, VUmc
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Contact:
Last name:
J. C.M. Scheepens, MD
Email:
j.c.m.scheepens-7@umcutrecht.nl
Investigator:
Last name:
A. M.E. Bruynzeel, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Radboud University Medical Center
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Contact:
Last name:
J. C.M. Scheepens, MD
Email:
j.c.m.scheepens-7@umcutrecht.nl
Investigator:
Last name:
H. D. Heerkens, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University Medical Center Utrecht
Address:
City:
Utrecht
Zip:
3584CX
Country:
Netherlands
Contact:
Last name:
J. C.M. Scheepens, MD
Email:
j.c.m.scheepens-7@umcutrecht.nl
Investigator:
Last name:
L. A. Daamen, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
M. P.W. Intven, MD, PhD
Email:
Sub-Investigator
Start date:
February 2024
Completion date:
January 2030
Lead sponsor:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Collaborator:
Agency:
Centre for Human Drug Research, Netherlands
Agency class:
Other
Collaborator:
Agency:
Dutch Pancreatic Cancer Group (DPCG)
Agency class:
Other
Source:
UMC Utrecht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06272162
