Pancreatic Cancer and Carbon Ion Radiotherapy
PACK
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Dec 2019
Longer than P75 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2019
CompletedFirst Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2025
CompletedMarch 10, 2026
March 1, 2026
5.9 years
December 9, 2019
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
survival
overall survival
12 month after radiation
Secondary Outcomes (6)
toxicity outcomes
48 Month after radiatoin
survival
12 month after radiation
Blood Parameters Ca 19-9
48 Month after radiation
Blood Parameters CEA
48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30
48 Month after radiation
- +1 more secondary outcomes
Study Arms (1)
Interventional arm
EXPERIMENTALCarbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hopsital Heidelberg
Heidelberg, 69120, Germany
Related Publications (1)
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.
PMID: 33004046DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 11, 2019
Study Start
December 3, 2019
Primary Completion
October 16, 2025
Study Completion
November 11, 2025
Last Updated
March 10, 2026
Record last verified: 2026-03