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Clinical Trials/NCT01027221
NCT01027221CompletedNot Applicable

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 Center4 sites in 1 country32 target enrollmentStarted: November 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
4
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

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

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 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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