MR-Guided Adaptive SBRT Of Primary Tumor For Pain Control In Metastatic PDAC

Study Overview

MR-Guided Adaptive SBRT of Primary Tumor for Pain Control in Metastatic PDAC

The MASPAC trial investigates the added benefit of MR-guided adaptive SBRT of the primary tumor embedded between standard chemotherapy cycles for pain control and prevention of pain in patients with metastatic PDAC (mPDAC).

Patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy) will be included and randomized between arm A, receiving MR-guided adaptive SBRT of the primary tumor combined with continuation of SoC-CT, and arm B, continuing SoC-CT without SBRT. Arm A: The primary tumor is treated with SBRT (6.6 Gy x 5) on a MR-LINAC in breath-hold technique. This scheme was shown to have a reasonable toxicity profile on a conventional LINAC. A low toxicity profile is even more important in patients with metastatic and therefore definitively incurable cancer. Therefore, treatment is performed on a MR-LINAC to deliver high doses to the tumor while keeping the toxicity profile as low as possible. For this purpose, daily adaptive planning is performed aiming to maintain stringent dose constraints for organs at risk (duodenum / stomach / bowel / kidney). Chemotherapy will be continued after SBRT. Arm B: Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.

Pancreatic Cancer

RADIATION: SBRT
DRUG: SOC chemotherapy

20-973

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-10-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-06
First Submitted that Met QC Criteria 2021-10-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-14
First Posted (ACTUAL) 2021-11-09	Results First Posted N/A	Last Verified 2022-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A: SBRT mPDAC patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy). The primary tumor is treated with SBRT (6.6Gy x 5) on a MR-LINAC in breath-hold technique. For this purpose, daily adaptive planning	RADIATION: SBRT online adaptive MR-guided hypofractionated stereotactic radiotherapy DRUG: SOC chemotherapy The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.
ACTIVE_COMPARATOR: Arm B: SOC Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.	DRUG: SOC chemotherapy The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A: SBRT

mPDAC patients not progressing after 8 weeks of standard of care systemic therapy (SoC-CT: minimum doublet chemotherapy). The primary tumor is treated with SBRT (6.6Gy x 5) on a MR-LINAC in breath-hold technique. For this purpose, daily adaptive planning

RADIATION: SBRT

online adaptive MR-guided hypofractionated stereotactic radiotherapy

DRUG: SOC chemotherapy

The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.

ACTIVE_COMPARATOR: Arm B: SOC

Continuing SoC-CT (according to clinical routine appr. 2 weeks after the previous cycle) without SBRT.

DRUG: SOC chemotherapy

The chemotherapy is given according to current standard of care, consisting of in minimum doublet - chemotherapy and excluding monotherapy regimens.

Primary Outcome Measures	Measure Description	Time Frame
Mean cumulative pain index	Mean Cumulative pain index: AUC of pain scores rated every 4 weeks until death or end of study using numeric rating scale (NRS, 0= no pain, 10 = worst pain) divided by number of multiples of 4 weeks since randomization	through study completion, at least 24 weeks or until death

Secondary Outcome Measures	Measure Description	Time Frame
Number of biliary complications	Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage	through study completion, at least 24 weeks or until death
Malnutrition	Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks	through study completion, at least 24 weeks or until death
Treatment toxicity	Treatment toxicity according to CTCAE v5.0	through study completion, at least 24 weeks or until death
Death from any cause		through study completion

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Georg Beyer, Dr.

Phone Number: +4989440072391

Email: Georg.Beyer@med.uni-muenchen.de

Study Contact Backup

Name: Ulrike Pflugradt

Phone Number:

Email: Ulrike.Pflugradt@med.uni-muenchen.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Male and female patients with histologically proven, metastatic pancreatic adenocarcinoma of the pancreatic head or body amenable for MR-guided adaptive SBRT with at least stable disease after 8 weeks of standard of care doublet chemotherapy
age >18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Ability to follow study instructions and likely to attend and complete all required visits

Subjects not able to give consent
Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical study
Simultaneous participation in another clinical study or participation in any clinical trial involving an investigational medicinal product or treatment within 30 days prior to beginning of this study
Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the study results, or may interfere with the subject's participation in this study
Women of child bearing potential or sexually active males not willing to use effective contraception while on treatment and 12 weeks after the end of treatment (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
Biopsy proven tumor invasion into the stomach and/or duodenum
Medically uncontrolled pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Heidelberg University
University of Zurich

Investigators

PRINCIPAL_INVESTIGATOR: Maximilian Niyazi, Prof. Dr., Depatment of Radiation Oncology, University Hospital, LMU Munich

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Pavic M, Niyazi M, Wilke L, Corradini S, Vornhulz M, Mansmann U, Al Tawil A, Fritsch R, Horner-Rieber J, Debus J, Guckenberger M, Belka C, Mayerle J, Beyer G. MR-guided adaptive stereotactic body radiotherapy (SBRT) of primary tumor for pain control in metastatic pancreatic ductal adenocarcinoma (mPDAC): an open randomized, multicentric, parallel group clinical trial (MASPAC). Radiat Oncol. 2022 Jan 25;17(1):18. doi: 10.1186/s13014-022-01988-6.

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