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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
Control group with 0Gy
University of Heidelberg
Heidelberg, Germany
RECRUITINGPurpose 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- tumor activity
Time frame: 2 years
To determine local control and recurrence patterns of colorectal liver metastases in a CT
Time frame: 2 years
To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
Time frame: 2 years
• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
Time frame: 2 years
• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
Time frame: 2 years
• To determine the T-cell activity in the resected liver tissue
Time frame: 2 years
• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
Time frame: 6 months
To determine the number of regulatory T-cells in the resected liver tissue
Time frame: 2 years
To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
Time frame: 2 years
To determine quality of life according to the EORTC QoL questionnaire after 12 months.
Time frame: 1 year
To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria
Time frame: 2 years
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