Clinical trial · Interventional
Pancreatic Cancer and Carbon Ion Radiotherapy
NCT04194268CI-TRIAL-00105183PACKcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Ion | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional arm
- description
- Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks
- interventionNames
- Radiation: Carbon Ion
Primary outcomes (1)
- measure
- survival
- timeFrame
- 12 month after radiation
- description
- overall survival
Secondary outcomes (6)
- measure
- toxicity outcomes
- timeFrame
- 48 Month after radiatoin
- description
- Incidence of grade 3/4 NCI-CTC-AE toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLiermann 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 33004046