Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Radiation: Carbon Ion

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Herfarth, Prof.; Phone Number: 38260 06221 56; Email: klaus.herfarth@med.uni-heidelberg.de
• Study Contact Backup: Name: Jakob Liermann, MD PhD; Phone Number: 8201 06221 56; Email: Jakob.liermann@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hopsital Heidelberg
    • Contact: Klaus Herfarth, MD PhD; Phone Number: 38260 +49 6221 56; Email: klaus.herfarth@med.uni-heidelberg.de
    • Contact: Jakob Liermann, MD PhD; Phone Number: 34699 +49 6221 56; Email: jakob.liermann@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	overall survival	12 month after radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
toxicity outcomes	Incidence of grade 3/4 NCI-CTC-AE toxicity	48 Month after radiatoin
survival	Progression free survival	12 month after radiation
Blood Parameters Ca 19-9	Change in Ca 19-9	48 Month after radiation
Blood Parameters CEA	Change in CEA levels	48 Month after radiation
Quality of life (QLQ) EORTC QLQ C30	Change on scoring on EORTC QLQ C30	48 Month after radiation
Quality of life EORTC QLQ Pan26	Change on scoring EORTC QLQ Pan26	48 Month after radiation

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Estimated): December 3, 2024
• Study Completion (Estimated): December 3, 2025

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: RADONK-PACK-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No