Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SBRT

SOC chemotherapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring metastatic pancreatic cancer, SBRT, MR linac, chemotherapy, pain control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Munich, Dep. of Radiation OncologyRecruiting
University Hospital of Heidelberg, Dep. of Radiation Oncology
University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: SBRT

Arm B: SOC

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of biliary complications

Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage

Malnutrition

Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks

Treatment toxicity

Treatment toxicity according to CTCAE v5.0

Death from any cause

Full Information

NCT ID

NCT05114213

First Posted

October 16, 2021

Last Updated

April 6, 2022

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Heidelberg University, University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT05114213

Brief Title

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

Acronym

MASPAC

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Heidelberg University, University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

metastatic pancreatic cancer, SBRT, MR linac, chemotherapy, pain control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: SBRT

Arm Type

Experimental

Arm Description

Arm Title

Arm B: SOC

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

SBRT

Other Intervention Name(s)

oMRgRT

Intervention Description

online adaptive MR-guided hypofractionated stereotactic radiotherapy

Intervention Type

Drug

Intervention Name(s)

SOC chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean cumulative pain index

Description

Time Frame

through study completion, at least 24 weeks or until death

Secondary Outcome Measure Information:

Title

Number of biliary complications

Description

Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage

Time Frame

through study completion, at least 24 weeks or until death

Title

Malnutrition

Description

Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks

Time Frame

through study completion, at least 24 weeks or until death

Title

Treatment toxicity

Description

Treatment toxicity according to CTCAE v5.0

Time Frame

through study completion, at least 24 weeks or until death

Title

Death from any cause

Time Frame

through study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Georg Beyer, Dr.

Phone

+4989440072391

Georg.Beyer@med.uni-muenchen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Ulrike Pflugradt

Ulrike.Pflugradt@med.uni-muenchen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maximilian Niyazi, Prof. Dr.

Organizational Affiliation

Depatment of Radiation Oncology, University Hospital, LMU Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Munich, Dep. of Radiation Oncology

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maximilian Niyazi, MD, MSc

Facility Name

University Hospital of Heidelberg, Dep. of Radiation Oncology

City

Heidelberg

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juliane Hörner-Rieber, PD Dr.

Facility Name

University Hospital of Zurich

City

Zürich

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Guckenberger, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35078490

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs