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

This study is currently recruiting participants.
Verified April 2012 by German Cancer Research Center
Sponsor:
Collaborator:
University of Heidelberg
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01027221
First received: December 4, 2009
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Primarily Resectable Pancreatic Cancer
 Radiation: neoadjuvant Photonradiation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • local control and recurrence patterns of pancreatic cancer relative to a standard as seen in historical controls [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • surgical morbidity in patients undergoing pancreatic resection who received this protocol treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • frequencies of tumor-reactive T-cells in blood and bone marrow [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • expression of migration-relevant adhesion molecules on tumor endothelial cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • expression of proinflammatory cytokines and activation-dependent, immune-associated transcriptionary factors in tumors and blood [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life according to the EORTC QoL questionnaire after 6, 12, 18 and 24 months [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Photonradiation
single fraction, 4D planned, image guided, Radiation at a dose of 0,5 Gy in IMRT-technique 2 days before resection
Active Comparator: 2 Gy
neoadjuvant Radiation of 2 Gy 2 days before resection
 Radiation: neoadjuvant Photonradiation
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 Photonradiation
single fraction, 4D-planned, image guided, 5 Gy Radiation to the tumor with a safety margin, in IMRT-technique 2 days before resection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027221

Locations
Germany
German Cancer Research Center Recruiting
Heidelberg, Germany, 69120
Contact: Peter Ernst Huber, Prof. PhD MD     +49-6221-422515     p.huber@dkfz.de    
Contact: Carmen Timke     +49-6221-422587     c.timke@dkfz.de    
Principal Investigator: Peter E. Huber, Prof. PhD MD            
Sub-Investigator: Carmen Timke            
Sub-Investigator: Falk Roeder, Dr.            
Sub-Investigator: Philipp Beckhove, PhD MD            
Clinic for General, Visceral and Transplantation Surgery Recruiting
Heidelberg, Germany, 69120
Contact: Hubertus Schmitz-Winnethal, Dr.         hubertus.schmitz-winnenthal@med.uni-heidelberg.de    
Sub-Investigator: Hubertus Schmitz-Winnethal, Dr.            
Sub-Investigator: Juergen Weitz, Prof. Dr.            
Sub-Investigator: Jens Werner, Prof. Dr.            
Sponsors and Collaborators
German Cancer Research Center
University of Heidelberg
Investigators
Principal Investigator: Peter E. Huber, Prof. PhD MD German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
  More Information

No publications provided by German Cancer Research Center

Additional 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
Study First Received: December 4, 2009
Last Updated: April 5, 2012
Health Authority: Germany: Federal Office for Radiation Protection

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

ClinicalTrials.gov processed this record on May 19, 2013