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

Colorectal Liver Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01191632
• Other study ID #: S081/2008
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 20, 2010
• Last updated: October 21, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: October 2010
• Source: Heidelberg University
• Contact: Juergen Weitz, MD
• Phone: +49 6221 56 6250
• Email: juergen.weitz[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• one 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
• No Radiation
Control group with 0Gy

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine local control and recurrence patterns of colorectal liver metastases in a CT		2 years	Yes
Secondary	To determine the progression-free survival in patients treated with low dose photon beam radiation therapy		2 years	No
Secondary	• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment		2 years	Yes
Secondary	• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment		2 years	Yes
Secondary	• To determine the T-cell activity in the resected liver tissue		2 years	No
Secondary	• To determine quality of life according to the EORTC QoL questionnaire after 6 months.		6 months	No
Secondary	To determine the number of regulatory T-cells in the resected liver tissue		2 years	No
Secondary	To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients		2 years	No
Secondary	To determine quality of life according to the EORTC QoL questionnaire after 12 months.		1 year	No
Secondary	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	Yes