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Trial Title:
Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
NCT ID:
NCT01191632
Condition:
Colorectal Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Conditions: Keywords:
T cell
surgery
radiation
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
one time radiation
Description:
Radiation: one time Radiation with an intensity of
0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery
Arm group label:
Radiation 0,5Gy
Arm group label:
Radiation 2Gy
Arm group label:
Radiation 5Gy
Intervention type:
Radiation
Intervention name:
No Radiation
Description:
Control group with 0Gy
Arm group label:
No radiation
Summary:
The efficiency of T cell based immunotherapies is affected by the insufficient migration
and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II
clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T
cell connected anti tumor immune response in colorectal liver metastases.
The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell
activity in situ, the number of regulatory T cells and the frequency of tumor reactive T
cells in the blood and bone marrow will be examined.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ability of subject to understand character and individual consequences of the
clinical trial
- Written informed consent (must be available before enrolment in the trial)
- Age ≥ 50 years
- Radiological urgently suspected colorectal liver metastasis
Exclusion Criteria:
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
Gender:
All
Minimum age:
50 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Juergen Weitz
Phone:
+49 6221 56 6250
Email:
juergen.weitz@med.uni-heidelberg.de
Contact backup:
Last name:
Christoph Reissfelder
Phone:
+49 6221 56 6250
Email:
christoph.reissfelder@med.uni-heidelberg.de
Start date:
March 2010
Completion date:
March 2012
Lead sponsor:
Agency:
Heidelberg University
Agency class:
Other
Source:
Heidelberg University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01191632
