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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01027221
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primarily Resectable Pancreatic Cancer Radiation: neoadjuvant photon radiation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2009
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: 0
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
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, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. expression of migration-relevant adhesion molecules on tumor endothelial cells [ Time Frame: 2 years ]
    expression of migration-relevant adhesion molecules on tumor endothelial cells

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027221


Locations
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Germany
Clinic for General, Visceral and Transplantation Surgery
Heidelberg, Germany, 69120
German Cancer Research Center
Heidelberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
Investigators
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Principal Investigator: Peter E. Huber, Prof. PhD MD German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01027221    
Other Study ID Numbers: IMPACT2010
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: November 2017
Keywords provided by German Cancer Research Center:
Low Dose Radiation
pancreatic cancer
Immunostimulation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases