Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
NCT ID: NCT01191632
Last Updated: 2010-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2010-03-31
2012-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation 0,5Gy
Radiation: one time Radiation with an intensity of 0.5 Gy Group A
Beginning on a weekday 48 hours before surgery
one time radiation
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
No radiation
Control group with 0Gy radiation
No Radiation
Control group with 0Gy
Radiation 2Gy
Radiation: one time Radiation with an intensity of
2.0 Gy Group B
Beginning on a weekday 48 hours before surgery
one time radiation
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
Radiation 5Gy
Radiation: one time Radiation with an intensity of
5 Gy Group C Beginning on a weekday 48 hours before surgery
one time radiation
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
Interventions
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one time radiation
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
No Radiation
Control group with 0Gy
Eligibility Criteria
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Inclusion Criteria
* Written informed consent (must be available before enrolment in the trial)
* Age ≥ 50 years
* Radiological urgently suspected colorectal liver metastasis
Exclusion Criteria
* Pregnancy and lactation
* no prior liver radiation
* liver metastasis must be resectable
50 Years
90 Years
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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Department of surgery, university of Heidelberg
Locations
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University of Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Reissfelder C, Timke C, Schmitz-Winnenthal H, Rahbari NN, Koch M, Klug F, Roeder F, Edler L, Debus J, Buchler MW, Beckhove P, Huber PE, Weitz J. A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer. BMC Cancer. 2011 Sep 30;11:419. doi: 10.1186/1471-2407-11-419.
Other Identifiers
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S081/2008
Identifier Type: -
Identifier Source: org_study_id