Pancreatic Cancer And Carbon Ion Radiotherapy

Study Overview

Pancreatic Cancer and Carbon Ion Radiotherapy

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.

N/A

Pancreatic Cancer

RADIATION: Carbon Ion

RADONK-PACK-2019

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-12-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-18
First Submitted that Met QC Criteria 2019-12-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-20
First Posted (ACTUAL) 2019-12-11	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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)

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)

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

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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