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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191632

Enrollment

Registered

2010-08-31

Start date

2010-03-31

Completion date

2012-03-31

Last updated

2010-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Liver Metastases

Keywords

T cell, surgery, radiation

Brief 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.

Interventions

RADIATIONone 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

RADIATIONNo Radiation

Control group with 0Gy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
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	2 years

Secondary

Measure	Time frame
To determine the progression-free survival in patients treated with low dose photon beam radiation therapy	2 years
• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment	2 years
• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment	2 years
• To determine the T-cell activity in the resected liver tissue	2 years
To determine local control and recurrence patterns of colorectal liver metastases in a CT	2 years
To determine the number of regulatory T-cells in the resected liver tissue	2 years
To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients	2 years
To determine quality of life according to the EORTC QoL questionnaire after 12 months.	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	2 years
• To determine quality of life according to the EORTC QoL questionnaire after 6 months.	6 months

Countries

Germany

Contacts

Primary ContactJuergen Weitz, MD

juergen.weitz@med.uni-heidelberg.de+49 6221 56 6250

Backup ContactChristoph Reissfelder, MD

christoph.reissfelder@med.uni-heidelberg.de+49 6221 56 6250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026