PACK
Pancreatic Cancer and Carbon Ion Radiotherapy
Rekrutierend
NCT-Nummer:
NCT04194268
Studienbeginn:
Dezember 2019
Letztes Update:
05.01.2024
Wirkstoff:
-
Indikation (Clinical Trials):
Pancreatic Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital Heidelberg
Collaborator:
-
Kontakt
Klaus Herfarth, Prof.
Kontakt:
Phone: 06221 56
Phone (ext.): 38260
E-Mail: klaus.herfarth@med.uni-heidelberg.de» Kontaktdaten anzeigen
Jakob Liermann, MD PhD
Kontakt:
Phone: 06221 56
Phone (ext.): 8201
E-Mail: Jakob.liermann@med.uni-heidelberg.de» Kontaktdaten anzeigen
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.
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
Primary outcome:
1. survival (Time Frame - 12 month after radiation):
overall survival
Secondary outcome:
1. toxicity outcomes (Time Frame - 48 Month after radiatoin):
Incidence of grade 3/4 NCI-CTC-AE toxicity
2. survival (Time Frame - 12 month after radiation):
Progression free survival
3. Blood Parameters Ca 19-9 (Time Frame - 48 Month after radiation):
Change in Ca 19-9
4. Blood Parameters CEA (Time Frame - 48 Month after radiation):
Change in CEA levels
5. Quality of life (QLQ) EORTC QLQ C30 (Time Frame - 48 Month after radiation):
Change on scoring on EORTC QLQ C30
6. Quality of life EORTC QLQ Pan26 (Time Frame - 48 Month after radiation):
Change on scoring EORTC QLQ Pan26
- Carbon Ion:
12 x 4 Gy (RBE)
Quelle: ClinicalTrials.gov
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