Primarily Resectable Pancreatic Cancer
Conditions
Keywords
Low Dose Radiation, pancreatic cancer, Immunostimulation
Brief 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.
Interventions
RADIATIONneoadjuvant photon radiation
single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
Sponsors
Heidelberg University
German Cancer Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 * American Society of Anesthesiologists (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity | 1 year | Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumoral activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment | 1 year | surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment |
| frequencies of tumor-reactive T-cells in blood and bone marrow | 2 years | frequencies of tumor-reactive T-cells in blood and bone marrow |
| local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls | 5 years | local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls |
| expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood | 2 years | expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood |
| quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months | 3 years | quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months |
| expression of migration-relevant adhesion molecules on tumor endothelial cells | 2 years | expression of migration-relevant adhesion molecules on tumor endothelial cells |
Countries
Germany
Outcome results
None listed