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

NCT06272162 | Not Yet Recruiting

• 3 other identifiers: NL85622.041.241503023U-0725
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

MR guided radiation therapy

Outcome Measures

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.

  Through study completion, an average of 18 months

Secondary Outcomes (15)

• Overall survival

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

• Patient reported Quality of Life EORTC QLQ-PAN26

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

• Patient reported Quality of Life EORTC QLQ-C30

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

• Patient reported Quality of Life EQ5D-5L

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

• The need of subsequent treatments

  Through study completion, an average of 18 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients in the intervention arm will receive locally ablative stereotactic MRgRT in addition to standard of care, consisting of 5 times 10 Gy MR guided radiotherapy.

Radiation: MR guided radiotherapy

Control arm

NO INTERVENTION

Patients randomized to the control arm will continue standard of care as described without additional local treatment.

Interventions

MR guided radiotherapy RADIATION

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

Intervention arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• 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

Study Sites (4)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Amsterdam University Medical Center, VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

Study Officials

• L. A. Daamen, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• M P.W. Intven, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• A. M.E. Bruynzeel, MD, PhD

  Amsterdam University Medical Center, VUmc

  PRINCIPAL INVESTIGATOR

• H. D. Heerkens, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• H. M.U. Peulen, MD, PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

• J. J. Bosch

  Centre of Human Drug Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lois Daamen, MD, PhD

CONTACT

+ 316 51223276; L.a.daamen-3@umcutrecht.nl

Jacobien Scheepens, MD

CONTACT

+31 6 21477044; j.c.m.scheepens-7@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator

Model Details: RCT

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 22, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: upon request

Locations

NL (4)