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Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194268
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Carbon Ion Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. survival [ Time Frame: 12 month after radiation ]
    overall survival


Secondary Outcome Measures :
  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


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
University Hospital Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases