MR-Guided Adaptive Stereotactic Body Radiotherapy (SBRT) of Primary Tumor for Pain Control in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) – a Randomized, Controlled Clinical Study
- Conditions
- C25Malignant neoplasm of pancreas
- Registration Number
- DRKS00025801
- Lead Sponsor
- MU Klinikum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 10
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
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
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
? ECOG >2
? 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •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
Name Time Method •Average pain on NRS at 24 weeks<br>•Time until definitive deterioration (TUDD) defined as increase of average pain on NRS of 3 points over baseline sustained over 4 weeks. <br>•Biliary complications defined as cholangitis or post-hepatic cholestasis requiring drainage.<br>•Nutritional status measuring bioimpedance-derived phase angle (BIA) every 12 weeks<br>•Death from any cause<br>•Treatment toxicity according to CTCAE v5.0<br>•Quality of life (EQ-5D-5L, FACT-Hepatobiliary Symptom Index – FHSI-8)<br>