Pancreatic Cancer and Carbon Ion Radiotherapy (PACK)

University Hospital Heidelberg

Status: Active, not recruiting

Conditions: Pancreatic Cancer

Treatments: Radiation: Carbon Ion

Study type: Interventional

Funder types: Other

Identifiers

NCT04194268

RADONK-PACK-2019

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Interventional arm

Experimental group

Description:

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

Treatment:

Radiation: Carbon Ion