Pancreatic Cancer
Conditions
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.
Interventions
RADIATIONCarbon Ion
12 x 4 Gy (RBE)
Sponsors
University Hospital Heidelberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival | 12 month after radiation | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Parameters Ca 19-9 | 48 Month after radiation | Change in Ca 19-9 |
| Blood Parameters CEA | 48 Month after radiation | Change in CEA levels |
| survival | 12 month after radiation | Progression free survival |
| Quality of life EORTC QLQ Pan26 | 48 Month after radiation | Change on scoring EORTC QLQ Pan26 |
| toxicity outcomes | 48 Month after radiatoin | Incidence of grade 3/4 NCI-CTC-AE toxicity |
| Quality of life (QLQ) EORTC QLQ C30 | 48 Month after radiation | Change on scoring on EORTC QLQ C30 |
Countries
Germany
Outcome results
None listed