PACK: Pancreatic Cancer and Carbon Ion Radiotherapy

• Sponsor: University Hospital Heidelberg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04194268
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Radiation: Carbon Ion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pancreatic Cancer and Carbon Ion Radiotherapy
• Actual Study Start Date: Dec 3, 2019
• Anticipated Primary Completion Date: Dec 3, 2021
• Anticipated Study Completion Date: Dec 3, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. survival [12 month after radiation]

   overall survival

Secondary Outcome Measures

1. toxicity outcomes [48 Month after radiatoin]

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

2. survival [12 month after radiation]

   Progression free survival

3. Blood Parameters Ca 19-9 [48 Month after radiation]

   Change in Ca 19-9

4. Blood Parameters CEA [48 Month after radiation]

   Change in CEA levels

5. Quality of life (QLQ) EORTC QLQ C30 [48 Month after radiation]

   Change on scoring on EORTC QLQ C30

6. Quality of life EORTC QLQ Pan26 [48 Month after radiation]

   Change on scoring EORTC QLQ Pan26

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hopsital Heidelberg	Heidelberg		Germany	69120

Sponsors and Collaborators

• University Hospital Heidelberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Juergen Debus, Head of Department, University Hospital Heidelberg
• ClinicalTrials.gov Identifier: NCT04194268
• Other Study ID Numbers: RADONK-PACK-2019
• First Posted: Dec 11, 2019
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Jun 23, 2021