Clinical Trial Record

Return to Clinical Trials

Pancreatic Cancer and Carbon Ion Radiotherapy


2019-12-03


2025-10-09


2025-12-09


25

Study Overview

Pancreatic Cancer and Carbon Ion Radiotherapy

Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.

N/A

  • Pancreatic Cancer
  • RADIATION: Carbon Ion
  • RADONK-PACK-2019

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-12-09  

N/A  

2025-02-18  

2019-12-09  

N/A  

2025-02-20  

2019-12-11  

N/A  

2025-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Interventional arm

Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks

RADIATION: Carbon Ion

  • 12 x 4 Gy (RBE)
Primary Outcome MeasuresMeasure DescriptionTime Frame
survivaloverall survival12 month after radiation
Secondary Outcome MeasuresMeasure DescriptionTime Frame
toxicity outcomesIncidence of grade 3/4 NCI-CTC-AE toxicity48 Month after radiatoin
survivalProgression free survival12 month after radiation
Blood Parameters Ca 19-9Change in Ca 19-948 Month after radiation
Blood Parameters CEAChange in CEA levels48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30Change on scoring on EORTC QLQ C3048 Month after radiation
Quality of life EORTC QLQ Pan26Change on scoring EORTC QLQ Pan2648 Month after radiation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Histologically confirmed, inoperable primary or local recurrent pancreatic cancer
  • Written informed consent (must be available before enrollment in the trial)
  • Karnofsky performance score > 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible)
  • Age ≥ 18 years

  • Exclusion Criteria:

  • No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging
  • Extensive lymphatic metastases
  • Disability of subject to understand character and individual consequences of the clinical trial
  • Distant metastases
  • Previous radiotherapy of the upper abdomen
  • Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT
  • Participation in another clinical study or observation period of competing trials, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Liermann J, Naumann P, Hommertgen A, Pohl M, Kieser M, Debus J, Herfarth K. Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective phase II PACK-study. BMC Cancer. 2020 Oct 1;20(1):947. doi: 10.1186/s12885-020-07434-8.