Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)
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ClinicalTrials.gov Identifier: NCT04194268 |
Recruitment Status :
Recruiting
First Posted : December 11, 2019
Last Update Posted : June 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Radiation: Carbon Ion | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pancreatic Cancer and Carbon Ion Radiotherapy |
Actual Study Start Date : | December 3, 2019 |
Estimated Primary Completion Date : | December 3, 2021 |
Estimated Study Completion Date : | December 3, 2023 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194268
Contact: Klaus Herfarth, Prof. | 06221 56 ext 38260 | klaus.herfarth@med.uni-heidelberg.de | |
Contact: Jakob Liermann, MD PhD | 06221 56 ext 8201 | Jakob.liermann@med.uni-heidelberg.de |
Germany | |
University Hopsital Heidelberg | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Klaus Herfarth, MD PhD +49 6221 56 ext 38260 klaus.herfarth@med.uni-heidelberg.de | |
Contact: Jakob Liermann, MD PhD +49 6221 56 ext 34699 jakob.liermann@med.uni-heidelberg.de |
Responsible Party: | Juergen Debus, Head of Department, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT04194268 |
Other Study ID Numbers: |
RADONK-PACK-2019 |
First Posted: | December 11, 2019 Key Record Dates |
Last Update Posted: | June 23, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |