DRKS00025801Active, not recruitingPhase 2
MR-Guided Adaptive Stereotactic Body Radiotherapy (SBRT) of Primary Tumor for Pain Control in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) – a Randomized, Controlled Clinical Study - MASPAC
MU Klinikum0 sites10 target enrollmentStarted: August 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
- •Written informed consent of the subject
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
- •? 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
- •Exclusion criteria regarding special restrictions for females:
- •? Current or planned pregnancy or nursing women
- •Indication-specific exclusion criteria:
- •? Previous pancreatic surgery
- •? Previous abdominal radiotherapy of the upper abdomen
- •? Patients with contraindications for MRI imaging (e.g. non-MRIcompatible
- •cardiac pacemaker or ICD / Cochlea implant / metal
- •implants / severe claustrophobia)
- •? Patients with contraindications for doublet-chemotherapy
- •? Patients with contraindications for MR-guided adaptive SBRT
- •? Biopsy proven tumor invasion into the stomach and/or duodenum
- •? Concomitant non-pancreatic malignancy. Patients being treated
- •for a non-pancreatic malignancy with tumor control for over 3
- •years are eligible.
- •? Medically uncontrolled pain
Investigators
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