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Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer | Clinical Trials | Clareo Health

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Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

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

NCT01027221•German Cancer Research Center

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Clinic for General, Visceral and Transplantation Surgery

Heidelberg, Germany

German Cancer Research Center

Heidelberg, Germany

Key Dates

Start Date

November 1, 2009

Primary Completion Date

September 1, 2019

Completion Date

September 1, 2019

Last Updated

June 10, 2021

Enrollment

ACTUAL participants

Conditions

Primarily Resectable Pancreatic Cancer

Interventions

neoadjuvant photon radiation

RADIATION

neoadjuvant photon radiation

RADIATION

neoadjuvant photon radiation

RADIATION