This project aims to explore the efficacy and safety of radiotherapy for asymptomatic pNET using delivery of radiotherapy by MR-linac in Multiple Endocrine Neoplasia 1 (MEN1) patients.
ID
Source
Brief title
Condition
- Endocrine and glandular disorders NEC
- Malignant and unspecified neoplasms gastrointestinal NEC
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the change in tumour size at control MRI at 12 months
follow-up.
Secondary outcome
Key secondary outcomes include indication for pancreatic resection, safety
(toxicity), radiological tumour characteristics, quality of life, and endocrine
and exocrine pancreas function, metastases free survival, overall survival and
tumour characteristics on follow-up MRI.
Background summary
Clinical decision making in pancreatic neuroendocrine tumours (pNET) is a major
challenge. The standard of care for pNET with curative intent is surgical
resection. Surgery for pNET is considered in tumours with a diameter of more
than 2 cm or rapid growth, however, associated short- and long-term morbidity
of pancreatic surgery is significant. Because of the relative unfavourable
risk-benefit ratio, there is a need for new treatment modalities for smaller
pNETs. Neuroendocrine tumours have shown to be radiosensitive. Using the
recently developed and implemented MR-linac system, high dose radiotherapy can
be delivered to the pancreas whilst sparing surrounding tissues.
Study objective
This project aims to explore the efficacy and safety of radiotherapy for
asymptomatic pNET using delivery of radiotherapy by MR-linac in Multiple
Endocrine Neoplasia 1 (MEN1) patients.
Study design
Prospective cohort study. Patients will be recruited from the Dutch MEN1 Study
Group (DMSG) cohort.
Intervention
High dose radiotherapy using MR-linac, with a dose on the tumour bed of a
minimum of 40 Gy in 5 fraction delivered in 2 weeks.
Study burden and risks
Adverse events related to the experimental intervention relate to toxicity of
radiotherapy to healthy pancreatic tissue and radiosensitive tissues near the
pancreatic area. A second risk associated with radiotherapy is development of
radiotherapy-induced tumours. Using MR-linac we can administer the dose highly
accurately, and keep strict dose limits for surrounding tissues. Nevertheless,
toxicity might occur. Neighbouring tissue and organs to the pancreas include:
Spine, Liver, Small bowel, Stomach, Duodenum, Kidney, Spleen. Patients
undergoing radiotherapy will actively be monitored for potential radiotoxicity
during the study and thereafter through the MEN1 follow-up program. We consider
the current study justifiable because MRgRT is expected to result in a lower
risk for progression, eventually resulting in a lower need for pancreatic
surgery.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
MEN1 patients diagnosed with pNET meeting the following criteria:
- lesions measuring between 2cm and 3cm.
- pNET lesions with a size between 1.0 and 2.0 cm and moderate growth of the
lesion (2-4 mm/ year) on sequential follow-up scans.
- pNET lesions with a size between 1.0 and 2.0 cm and minimal growth of the
lesion (1 mm/ year) reconfirmed on 3 or more sequential follow-up scans.
- Patients with in situ remaining 1.0 - 2.0 cm lesions after previous resection
of a larger lesion.
Exclusion criteria
- Suspected malignant pNET as per the tumour board assessment, including the
criteria:
- pNET lesions of more than 3 cm in size
- rapid growth of pNET lesions with more than 4mm per year
- Symptomatic pNET because of hormone production, with the exception of
gastrinomas which are located in the submucosa of the duodenum
- concurrent treatment with a somatostatin analog
- concurrent treatment with chemotherapy
- peptide receptor radionuclide therapy in the past 12 months
- history of radiotherapy in the upper abdominal region
- MRI contraindications as per usual clinical care, such as claustrophobia and
metal or electronic implants not compatible with MRI.
- Pregnancy
- (Other) metastatic disease
- WHO performance score 3-4
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05037461 |
| CCMO | NL77809.041.21 |