Low Dose Radiation To Improve T-Cell Infiltration In Pancreatic Cancer

Study Overview

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

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.

N/A

Primarily Resectable Pancreatic Cancer

RADIATION: neoadjuvant photon radiation
RADIATION: neoadjuvant photon radiation
RADIATION: neoadjuvant photon radiation

IMPACT2010

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-06-07
First Submitted that Met QC Criteria 2009-12-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-10
First Posted (ACTUAL) 2009-12-07	Results First Posted N/A	Last Verified 2017-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: 0 primarily resectable pancreatic cancer patients	RADIATION: neoadjuvant photon radiation single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
ACTIVE_COMPARATOR: 0,5 Gy neoadjuvant Radiation of 0,5 Gy two days before resection	RADIATION: neoadjuvant photon radiation single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection
ACTIVE_COMPARATOR: 2 Gy neoadjuvant Radiation of 2 Gy 2 days before resection	RADIATION: neoadjuvant photon radiation single fraction, 4D-planned, image guided, 2 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection
ACTIVE_COMPARATOR: 5 Gy neoadjuvant Radiation of 5 Gy 2 days before resection	RADIATION: neoadjuvant photon radiation single fraction, four dimensions (4D) planned, image guided, Radiation at a dose of 0,5 Gy in Intensity modulated radiotherapy (IMRT)-technique 2 days before resection RADIATION: neoadjuvant photon radiation single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

Primary Outcome Measures	Measure Description	Time Frame
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	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

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Heidelberg University

Investigators

PRINCIPAL_INVESTIGATOR: Peter E. Huber, Prof. PhD MD, German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Resources

PatientS

Caregivers

Clinical Trial Record