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Consolidative MR-Guided Adaptive Radiotherapy Combined with Hyperthermia in Locally Advanced Pancreatic Cancer Patients Not Suitable for Resection After Induction Chemotherapy

Consolidative MR-Guided Adaptive Radiotherapy Combined with Hyperthermia in Locally Advanced Pancreatic Cancer Patients Not Suitable for Resection After Induction Chemotherapy - HOTPANC (Hyperthermia and Online-adaptive Treatment in Pancreatic Cancer)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040407
Enrollment
16
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C25

Interventions

Group 1: A total of 5 radiotherapy and 5 hyperthermia sessions are planned, which will be carried out twice a week. Fractionation scheme: 5 × 6.6 Gy with a simultaneous integrated boost (SIB) of 5 x 8

Sponsors

LMU Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Locally advanced pancreatic cancer (LAPC) not suitable for resection after induction chemotherapy 2. Restaging without progression 3. ECOG performance status 0-2 4. Ca 19-9 =500 U/ml 5. Ability to understand the nature and individual consequences of the clinical trial and to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Evidence of metastatic disease or Ca 19-9 >500 U/ml 2. Duodenal or gastric luminal infiltration on endoscopic evaluation 3. Metal bile duct stenting 4. Previous abdominal radiotherapy 5. Pregnant or breast-feeding females 6. Patients with contraindications for magnet resonance imaging (MRI) (non-MRI-compatible cardiac pacemaker or ICD, Cochlea implant, metal implants, severe claustrophobia) 7. Contraindications for hyperthermia (e.g., implanted heatsensitive devices, abdominal aortic aneurysm, etc.) 8. Patients without legal capacity or unable to understand the nature, significance and consequences of the study 9. Simultaneous participation in other interventional trials which could interfere with this trial

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the frequency of serious adverse events (SAE`s) associated with radiotherapy or hyperthermia, defined as Common Terminology Criteria for Adverse Events version 6.0 grade = 3 toxicity, measured from the start of radiotherapy to 12 months after radiotherapy.

Secondary

MeasureTime frame
-Local control: Time from the start of radiotherapy to the first documented local recurrence - Freedom from distant progression (FFDP): Time from the start of radiotherapy to the first evidence of distant metastasis -Overall survival (OS): Time from the start of radiotherapy to death -Systemic therapy-free interval (STFI): Time from last systemic treatment before radiotherapy to the start of the next systemic treatment -Quality of life according to EORTC QLQ-C30 and PAN26 at baseline, at the end of radiotherapy and 3 and 12 months after the end of radiotherapy

Countries

Germany

Contacts

Public ContactPaul Rogowski

Klinik und Poliklinik für Strahlentherapie und Radioonkologie

paul.rogowski@med.uni-muenchen.de+49 89 4400 74511

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026