Pancreatic Cancer and Carbon Ion Radiotherapy

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Carbon Ion

• Registration Number: NCT04194268
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-03
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-10-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Carbon Ion	Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks

Primary Outcome Measures

Name	Time	Method
survival	12 month after radiation	overall survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hopsital Heidelberg; 🇩🇪 Heidelberg, Germany