Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients

NCT05037461 | Recruiting DMC

• 1 other identifier: NL77809.041.21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with the Multiple Endocrine Neoplasia type 1 (MEN1) syndrome are genetically predisposed for developping multiple pancreatic neuro-endocrine tumours (pNET). The management of small (pNET) in both MEN1 and sporadic cases, pose a major clinical challenge. At present, pancreatic surgery is the only curative treatment but it is associated with high morbidity. To reduce the morbidity ascosiated with surgery and thereby potentially improve quality of life for MEN1 patients introduction of less invasive techniques for treatment of pNET is important. High-dose-high precision MR-guided radiotherapy (MRgRT) holds promise as a new less invasive treatment option for pNET. The aim of this study is to assess efficiacy and safety of MRgRT for treatment of pNET in MEN1 patients.

Conditions

Neuroendocrine Tumor of Pancreas; Multiple Endocrine Neoplasia Type 1

Outcome Measures

Primary Outcomes (1)

• Change in tumor size

  Change in maximal diameter of pNET measured at follow-up MRI

  12 months

Secondary Outcomes (16)

• Tumour progression

  12 months

• Pancreatic surgery

  12 months

• Toxicity of radiotherapy

  12 months

• Health-related quality of life by SF-36

  6 months, 12 months

• Health-related quality of life by Eq5D

  6 months, 12 months

Study Arms (1)

High-dose-high precision MR-guided radiotherapy

EXPERIMENTAL

Radiotherapy for pancreatic NET will be delivered in an image-guided, hypofractionated scheme of 5 fractions of 8 Gy, prescribed to 95% of the planning target volume (PTV). Treatment is delivered on alternate days 2 or 3 times a week with a maximum overall treatment time of 14 days on the 1.5T MR-Linac (Elekta Unity MR-Linac). The Gross Tumor Volume (GTV) is defines as the pNET visible on pre-treatment CT and MRI scan. No clinical target volume (CTV) is used. The PTV is made by adding a 3mm margin to the GTV. The treatment plan is a 9-14 field intensity modulated radiotherapy (IMRT) plan with dose prescribed to 95% of the PTV. While respecting the dose constraints to adjacent tissues

Radiation: High-dose-high precision MR-guided radiotherapy

Interventions

High-dose-high precision MR-guided radiotherapy RADIATION

MR-guided radiotherapy as described in the group information

High-dose-high precision MR-guided radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• J.M. de Laat: lead
• Radboud University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Maastricht University Medical Center: collaborator
• Leiden University Medical Center: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Adenoma, Islet Cell; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Multiple Endocrine Neoplasia; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Joanne M de Laat, Md, PhD

CONTACT

+31302507397; J.M.deLaat-4@umcutrecht.nl

Gerlof D Valk, MD, PhD

CONTACT

+31302507397; G.D.Valk@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (Md, PhD)

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 8, 2021
• Study Start: May 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon closure of the study database untill a minumum of 15 years
• Access Criteria: Upon reasonable request

Locations

NL (1)