Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)

March 6, 2026 updated by: Juergen Debus, University Hospital Heidelberg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hopsital Heidelberg

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks
Radiation: Carbon Ion
12 x 4 Gy (RBE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 12 month after radiation
overall survival
12 month after radiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicity outcomes
Time Frame: 48 Month after radiatoin
Incidence of grade 3/4 NCI-CTC-AE toxicity
48 Month after radiatoin
survival
Time Frame: 12 month after radiation
Progression free survival
12 month after radiation
Blood Parameters Ca 19-9
Time Frame: 48 Month after radiation
Change in Ca 19-9
48 Month after radiation
Blood Parameters CEA
Time Frame: 48 Month after radiation
Change in CEA levels
48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30
Time Frame: 48 Month after radiation
Change on scoring on EORTC QLQ C30
48 Month after radiation
Quality of life EORTC QLQ Pan26
Time Frame: 48 Month after radiation
Change on scoring EORTC QLQ Pan26
48 Month after radiation

Collaborators and Investigators

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

Sponsor

University Hospital Heidelberg

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

October 16, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADONK-PACK-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Carbon Ion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe