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Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Carbon Ion
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hopsital HeidelbergRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks

Outcomes

Primary Outcome Measures

survival
overall survival

Secondary Outcome Measures

toxicity outcomes
Incidence of grade 3/4 NCI-CTC-AE toxicity
survival
Progression free survival
Blood Parameters Ca 19-9
Change in Ca 19-9
Blood Parameters CEA
Change in CEA levels
Quality of life (QLQ) EORTC QLQ C30
Change on scoring on EORTC QLQ C30
Quality of life EORTC QLQ Pan26
Change on scoring EORTC QLQ Pan26

Full Information

First Posted
December 9, 2019
Last Updated
June 21, 2021
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT04194268
Brief Title
Pancreatic Cancer and Carbon Ion Radiotherapy
Acronym
PACK
Official Title
Pancreatic Cancer and Carbon Ion Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
December 3, 2021 (Anticipated)
Study Completion Date
December 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks
Intervention Type
Radiation
Intervention Name(s)
Carbon Ion
Intervention Description
12 x 4 Gy (RBE)
Primary Outcome Measure Information:
Title
survival
Description
overall survival
Time Frame
12 month after radiation
Secondary Outcome Measure Information:
Title
toxicity outcomes
Description
Incidence of grade 3/4 NCI-CTC-AE toxicity
Time Frame
48 Month after radiatoin
Title
survival
Description
Progression free survival
Time Frame
12 month after radiation
Title
Blood Parameters Ca 19-9
Description
Change in Ca 19-9
Time Frame
48 Month after radiation
Title
Blood Parameters CEA
Description
Change in CEA levels
Time Frame
48 Month after radiation
Title
Quality of life (QLQ) EORTC QLQ C30
Description
Change on scoring on EORTC QLQ C30
Time Frame
48 Month after radiation
Title
Quality of life EORTC QLQ Pan26
Description
Change on scoring EORTC QLQ Pan26
Time Frame
48 Month after radiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Herfarth, Prof.
Phone
06221 56
Ext
38260
Email
klaus.herfarth@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Liermann, MD PhD
Phone
06221 56
Ext
8201
Email
Jakob.liermann@med.uni-heidelberg.de
Facility Information:
Facility Name
University Hopsital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Herfarth, MD PhD
Phone
+49 6221 56
Ext
38260
Email
klaus.herfarth@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Jakob Liermann, MD PhD
Phone
+49 6221 56
Ext
34699
Email
jakob.liermann@med.uni-heidelberg.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
33004046
Citation
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.
Results Reference
derived

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Pancreatic Cancer and Carbon Ion Radiotherapy

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