Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
- Conditions
- Primarily Resectable Pancreatic Cancer
- Interventions
- Radiation: neoadjuvant photon radiation
- Registration Number
- NCT01027221
- Lead Sponsor
- German Cancer Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0,5 Gy neoadjuvant photon radiation neoadjuvant Radiation of 0,5 Gy two days before resection 2 Gy neoadjuvant photon radiation neoadjuvant Radiation of 2 Gy 2 days before resection 5 Gy neoadjuvant photon radiation neoadjuvant Radiation of 5 Gy 2 days before resection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method expression of migration-relevant adhesion molecules on tumor endothelial cells 2 years expression of migration-relevant adhesion molecules on tumor endothelial cells
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
frequencies of tumor-reactive T-cells in blood and bone marrow 2 years frequencies of tumor-reactive T-cells in blood and bone marrow
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
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
Trial Locations
- Locations (2)
Clinic for General, Visceral and Transplantation Surgery
🇩🇪Heidelberg, Germany
German Cancer Research Center
🇩🇪Heidelberg, Germany