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

German Cancer Research Center2 sites in 1 country32 target enrollmentNovember 2009

ConditionsPrimarily Resectable Pancreatic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primarily Resectable Pancreatic Cancer
Sponsor: German Cancer Research Center
Enrollment: 32
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

September 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

German Cancer Research Center

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

expression of migration-relevant adhesion molecules on tumor endothelial cells(2 years)
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls(5 years)
frequencies of tumor-reactive T-cells in blood and bone marrow(2 years)
expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood(2 years)
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months(3 years)
surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment(1 year)