Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases

Heidelberg University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Colorectal Liver Metastases

Treatments: Radiation: one time radiation; Radiation: No Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01191632

S081/2008

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Radiation 0,5Gy

Active Comparator group

Description:

Radiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery

Treatment:

Radiation: one time radiation

No radiation

Active Comparator group

Description:

Control group with 0Gy radiation

Treatment:

Radiation: No Radiation

Radiation 2Gy

Active Comparator group

Description:

Radiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery

Treatment:

Radiation: one time radiation

Radiation 5Gy

Active Comparator group

Description:

Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery

Treatment:

Radiation: one time radiation