Clinical trial NCT01027221: Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer
Official title: Randomised Phase I/II Trial in Order to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Neoadjuvant Low-Dose-Radiation Therapy in Primarily Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primarily Resectable Pancreatic Cancer
Keywords: Low Dose Radiation
pancreatic cancer
Immunostimulation
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2009-12-07
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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
* 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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
timeFrame: 5 years
measure: surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment
timeFrame: 1 year
measure: frequencies of tumor-reactive T-cells in blood and bone marrow
timeFrame: 2 years
measure: expression of migration-relevant adhesion molecules on tumor endothelial cells
timeFrame: 2 years
measure: expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood
timeFrame: 2 years
measure: quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
timeFrame: 3 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinic for General, Visceral and Transplantation Surgery
city: Heidelberg
country: Germany
facility: German Cancer Research Center
Study officials:
affiliation: German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
name: Peter E. Huber, Prof. PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timke C, Winnenthal HS, Klug F, Roeder FF, Bonertz A, Reissfelder C, Rochet N, Koch M, Tjaden C, Buechler MW, Debus J, Werner J, Beckhove P, Weitz J, Huber PE. Randomized controlled phase I/II study to investigate immune stimulatory effects by low dose radiotherapy in primarily operable pancreatic cancer. BMC Cancer. 2011 Apr 13;11:134. doi: 10.1186/1471-2407-11-134.