Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients
Phase 1/Phase 2
50 Years
90 Years
50 Years
90 Years
Open (Enrolling)
Both
Colorectal Liver Metastases
Both
Colorectal Liver Metastases
Trial Information
Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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- tumor activity
Outcome Time Frame:
2 years
Safety Issue:
Yes
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
S081/2008
NCT ID:
NCT01191632
Start Date:
March 2010
Completion Date:
March 2012
Related Keywords:
- Colorectal Liver Metastases
- T cell
- surgery
- radiation
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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