Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
Conditions
Primarily Resectable Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Low Dose Radiation, pancreatic cancer, Immunostimulation
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: neoadjuvant Photonradiation Type: Radiation
Name: neoadjuvant Photonradiation Type: Radiation
Name: neoadjuvant Photonradiation Type: Radiation
Overall Status
Recruiting
Summary
Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Both
Criteria: Inclusion Criteria:

- Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.

- No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)

- 18 years of age or older

- ASA Performance status of 1 to 3

- Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment

- Informed consent

Exclusion Criteria:

- Locally irresectable pancreatic cancer

- distant metastases

- medically unfit for surgery

- Pregnant or lactating women

- prior chemotherapy or radiation treatment

- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation

- Unwillingness to participate or inability to comply with the protocol for the duration of the study

- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery

- Participation in other interventional trials
Locations
Clinic for General, Visceral and Transplantation Surgery
Heidelberg, Germany
Status: Recruiting
Contact: Hubertus Schmitz-Winnethal, Dr. - hubertus.schmitz-winnenthal@med.uni-heidelberg.de
German Cancer Research Center
Heidelberg, Germany
Status: Recruiting
Contact: Peter Ernst Huber, Prof. PhD MD - +49-6221-422515 - p.huber@dkfz.de
Start Date
November 2009
Completion Date
December 2012
Sponsors
German Cancer Research Center
Source
German Cancer Research Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page