Pancreatic CancerPACKNCT04194268
Pancreatic Cancer and Carbon Ion Radiotherapy
A study testing Carbon Ion in people with Pancreatic Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Carbon Ion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2019to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Carbon Ion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon IonRadiation
12 x 4 Gy (RBE)
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks Receives: Radiation: Carbon Ion |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
overall survival
Measured: 12 month after radiation
Secondary outcomes (6)
toxicity outcomes
Incidence of grade 3/4 NCI-CTC-AE toxicity
Measured: 48 Month after radiatoin
survival
Progression free survival
Measured: 12 month after radiation
Blood Parameters Ca 19-9
Change in Ca 19-9
Measured: 48 Month after radiation
Blood Parameters CEA
Change in CEA levels
Measured: 48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30
Change on scoring on EORTC QLQ C30
Measured: 48 Month after radiation
Quality of life EORTC QLQ Pan26
Change on scoring EORTC QLQ Pan26
Measured: 48 Month after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start3 Dec 2019
- Primary completion16 Oct 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194268
- Sponsor's protocol ID
- RADONK-PACK-2019
- Acronym
- PACK
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33004046
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer and Carbon Ion Radiotherapy
- ClinicalTrials.gov ID
- NCT04194268
- Acronym / sponsor ID
- PACK / RADONK-PACK-2019
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Radiation: Carbon IonCarbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Ion12 x 4 Gy (RBE) | Radiation | Interventional arm |
Primary outcome
survival
Time frame: 12 month after radiation
overall survival
6 secondary outcomes
toxicity outcomes
Time frame: 48 Month after radiatoin
survival
Time frame: 12 month after radiation
Blood Parameters Ca 19-9
Time frame: 48 Month after radiation
Blood Parameters CEA
Time frame: 48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30
Time frame: 48 Month after radiation
Quality of life EORTC QLQ Pan26
Time frame: 48 Month after radiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 33004046Liermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ion in people with Pancreatic Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 12 month after radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.