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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01191632
First received: August 20, 2010
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Colorectal Liver Metastases
Radiation: one time radiation
Radiation: No Radiation
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine local control and recurrence patterns of colorectal liver metastases in a CT [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine the progression-free survival in patients treated with low dose photon beam radiation therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • • To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • • To determine the T-cell activity in the resected liver tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • • To determine quality of life according to the EORTC QoL questionnaire after 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine the number of regulatory T-cells in the resected liver tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine quality of life according to the EORTC QoL questionnaire after 12 months. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiation 0,5Gy

Radiation: one time Radiation with an intensity of 0.5 Gy Group A

Beginning on a weekday 48 hours before surgery

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

Active Comparator: No radiation
Control group with 0Gy radiation
Radiation: No Radiation
Control group with 0Gy
Active Comparator: Radiation 2Gy

Radiation: one time Radiation with an intensity of

2.0 Gy Group B

Beginning on a weekday 48 hours before surgery

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

Active Comparator: Radiation 5Gy

Radiation: one time Radiation with an intensity of

5 Gy Group C Beginning on a weekday 48 hours before surgery

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


  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191632

Contacts
Contact: Juergen Weitz, MD +49 6221 56 6250 juergen.weitz@med.uni-heidelberg.de
Contact: Christoph Reissfelder, MD +49 6221 56 6250 christoph.reissfelder@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Juergen Weitz    +49 6221 56 6250    juergen.weitz@med.uni-heidelberg.de   
Contact: Christoph Reissfelder    +49 6221 56 6250    christoph.reissfelder@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juergen Weitz, Department of surgery, university of Heidelberg
ClinicalTrials.gov Identifier: NCT01191632     History of Changes
Other Study ID Numbers: S081/2008
Study First Received: August 20, 2010
Last Updated: October 21, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
T cell
surgery
radiation

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014