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OpenTrials
Completed

NCT Number: NCT04194268

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hopsital Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon Ion

Radiation

12 x 4 Gy (RBE)

Primary outcomes

  1. survival

    Time frame: 12 month after radiation

    overall survival

Secondary outcomes

  1. toxicity outcomes

    Time frame: 48 Month after radiatoin

    Incidence of grade 3/4 NCI-CTC-AE toxicity

  2. survival

    Time frame: 12 month after radiation

    Progression free survival

  3. Blood Parameters Ca 19-9

    Time frame: 48 Month after radiation

    Change in Ca 19-9

  4. Blood Parameters CEA

    Time frame: 48 Month after radiation

    Change in CEA levels

  5. Quality of life (QLQ) EORTC QLQ C30

    Time frame: 48 Month after radiation

    Change on scoring on EORTC QLQ C30

  6. Quality of life EORTC QLQ Pan26

    Time frame: 48 Month after radiation

    Change on scoring EORTC QLQ Pan26

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: PACK

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2019
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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