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

Phase 1

• Conditions: Colorectal Liver Metastases
• Interventions: Radiation: one time radiation; Radiation: No Radiation

• Registration Number: NCT01191632
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-10-22
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation 0,5Gy	one time radiation	Radiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery
No radiation	No Radiation	Control group with 0Gy radiation
Radiation 2Gy	one time radiation	Radiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery
Radiation 5Gy	one time radiation	Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 quality of life according to the EORTC QoL questionnaire after 6 months.	6 months
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

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Germany