Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05114213
Recruitment Status : Recruiting
First Posted : November 9, 2021
Last Update Posted : April 14, 2022
Sponsor:
Collaborators:
Heidelberg University
University of Zurich
Information provided by (Responsible Party):
Prof. Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: SBRT Drug: SOC chemotherapy Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MR-Guided Adaptive Stereotactic Body Radiotherapy (SBRT) of Primary Tumor for Pain Control in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - a Randomized, Controlled Clinical Study
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


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 is performed aiming to maintain stringent dose constraints for organs at risk (duodenum / stomach / bowel / kidney). Chemotherapy will be continued after SBRT.
Radiation: SBRT
online adaptive MR-guided hypofractionated stereotactic radiotherapy
Other Name: oMRgRT

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 :
  1. Mean cumulative pain index [ Time Frame: through study completion, at least 24 weeks or until death ]
    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


Secondary Outcome Measures :
  1. Number of biliary complications [ Time Frame: through study completion, at least 24 weeks or until death ]
    Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage

  2. Malnutrition [ Time Frame: through study completion, at least 24 weeks or until death ]
    Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks

  3. Treatment toxicity [ Time Frame: through study completion, at least 24 weeks or until death ]
    Treatment toxicity according to CTCAE v5.0

  4. Death from any cause [ Time Frame: through study completion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05114213


Contacts
Layout table for location contacts
Contact: Georg Beyer, Dr. +4989440072391 Georg.Beyer@med.uni-muenchen.de
Contact: Ulrike Pflugradt Ulrike.Pflugradt@med.uni-muenchen.de

Locations
Layout table for location information
Germany
University of Munich, Dep. of Radiation Oncology Recruiting
Munich, Bavaria, Germany, 81377
Principal Investigator: Maximilian Niyazi, MD, MSc         
University Hospital of Heidelberg, Dep. of Radiation Oncology Not yet recruiting
Heidelberg, Germany
Contact: Juliane Hörner-Rieber, PD Dr.         
Switzerland
University Hospital of Zurich Not yet recruiting
Zürich, Switzerland
Contact: Matthias Guckenberger, Prof. Dr.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Heidelberg University
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Maximilian Niyazi, Prof. Dr. Depatment of Radiation Oncology, University Hospital, LMU Munich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Dr. med. Dipl.-Phys. Maximilian Niyazi, Vice Chair, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT05114213    
Other Study ID Numbers: 20-973
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich:
metastatic pancreatic cancer
SBRT
MR linac
chemotherapy
pain control
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases