Pancreatic Cancer and Carbon Ion Radiotherapy | NCT04194268

Studies
Pancreatic Cancer and Carbon Ion Radiotherapy

NCT04194268

Sponsor

University Hospital Heidelberg

Status

Completed

Last Update Posted

Mar 10, 2026Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Pancreatic Cancer

Interventions

Carbon Ion

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2019Actual

Primary Completion Date

Oct 16, 2025Actual

Completion Date

Nov 11, 2025Actual

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

Dec 9, 2019

First Posted Date

Dec 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional arm	Experimental	Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks	Radiation: Carbon Ion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbon Ion	Radiation	12 x 4 Gy (RBE)	Interventional arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival	overall survival	12 month after radiation

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hopsital Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33004046	Derived	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.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms