Pancreatic Cancer Clinical Trial
— MASPACOfficial 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
NCT number | NCT05114213 |
Other study ID # | 20-973 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 15, 2021 |
Est. completion date | May 2024 |
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).
Status | Recruiting |
Enrollment | 92 |
Est. completion date | May 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Heidelberg, Dep. of Radiation Oncology | Heidelberg | |
Germany | University of Munich, Dep. of Radiation Oncology | Munich | Bavaria |
Switzerland | University Hospital of Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich | Heidelberg University, University of Zurich |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Malnutrition | Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks | through study completion, at least 24 weeks or until death | |
Secondary | Treatment toxicity | Treatment toxicity according to CTCAE v5.0 | through study completion, at least 24 weeks or until death | |
Secondary | Death from any cause | through study completion |
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