Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer (IMPACT2010)

June 7, 2021 updated by: German Cancer Research Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • German Cancer Research Center
      • Heidelberg, Germany, 69120
        • Clinic for General, Visceral and Transplantation Surgery

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.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION
primarily resectable pancreatic cancer patients
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
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
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
ACTIVE_COMPARATOR: 2 Gy
neoadjuvant Radiation of 2 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, 2 Gy Radiation to the tumor with a safety margin, in 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
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, 2 Gy Radiation to the tumor with a safety margin, in 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls
Time Frame: 5 years
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
Time Frame: 1 year
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
Time Frame: 2 years
frequencies of tumor-reactive T-cells in blood and bone marrow
2 years
expression of migration-relevant adhesion molecules on tumor endothelial cells
Time Frame: 2 years
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
Time Frame: 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
Time Frame: 3 years
quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months
3 years

Collaborators and Investigators

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

Sponsor

German Cancer Research Center

Collaborators

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 and helpful links

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

General Publications

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 Major Dates

Study Start (ACTUAL)

November 1, 2009

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (ESTIMATE)

December 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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