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

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ClinicalTrials.gov Identifier: NCT01027221
Recruitment Status : Recruiting
First Posted : December 7, 2009
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]

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 ]
  2. surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment [ Time Frame: 1 year ]
  3. frequencies of tumor-reactive T-cells in blood and bone marrow [ Time Frame: 2 years ]
  4. expression of migration-relevant adhesion molecules on tumor endothelial cells [ Time Frame: 2 years ]
  5. expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionally factors in tumors and blood [ Time Frame: 2 years ]
  6. quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months [ Time Frame: 3 years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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

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
Germany
Clinic for General, Visceral and Transplantation Surgery Recruiting
Heidelberg, Germany, 69120
Contact: Christin Tjaden, Dr. med.       Christine.Tjaden@med.uni-heidelberg.de   
German Cancer Research Center Recruiting
Heidelberg, Germany, 69120
Contact: Peter Ernst Huber, Prof. PhD MD    +49-6221-422515    p.huber@dkfz.de   
Contact: Niels Nicolay, Dr. med.    +49 6221 42 2587    n.nicolay@dkfz-heidelberg.de   
Principal Investigator: Peter E. Huber, Prof. PhD MD         
Sub-Investigator: Chrstin Tjaden, Dr. med.         
Sub-Investigator: Stefan Rieken, Dr. med.         
Sub-Investigator: Philipp Beckhove, PhD MD         
Sponsors and Collaborators
German Cancer Research Center
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01027221     History of Changes
Other Study ID Numbers: IMPACT2010
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by German Cancer Research Center:
Low Dose Radiation
pancreatic cancer
Immunostimulation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases