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Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
Conditions
Colorectal Liver Metastases
Conditions: official terms
Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
T cell, surgery, radiation
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: one time radiation
Type: Radiation
Name: No Radiation
Type: Radiation
Overall Status
Recruiting
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.
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
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 50 Years
Gender: Both
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
- 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
Location
University of Heidelberg
Heidelberg, Germany
Status: Recruiting
Contact: Juergen Weitz - +49 6221 56 6250 - juergen.weitz@med.uni-heidelberg.de
Start Date
March 2010
Completion Date
March 2012
Sponsors
Heidelberg University
Source
Heidelberg University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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