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

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ClinicalTrials.gov Identifier: NCT01191632
Recruitment Status : Unknown
Verified October 2010 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : August 31, 2010
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Heidelberg University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Liver Metastases Radiation: one time radiation Radiation: No Radiation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine local control and recurrence patterns of colorectal liver metastases in a CT [ Time Frame: 2 years ]
  2. To determine the progression-free survival in patients treated with low dose photon beam radiation therapy [ Time Frame: 2 years ]
  3. • To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment [ Time Frame: 2 years ]
  4. • To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment [ Time Frame: 2 years ]
  5. • To determine the T-cell activity in the resected liver tissue [ Time Frame: 2 years ]
  6. • To determine quality of life according to the EORTC QoL questionnaire after 6 months. [ Time Frame: 6 months ]
  7. To determine the number of regulatory T-cells in the resected liver tissue [ Time Frame: 2 years ]
  8. To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients [ Time Frame: 2 years ]
  9. To determine quality of life according to the EORTC QoL questionnaire after 12 months. [ Time Frame: 1 year ]
  10. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191632


Contacts
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juergen Weitz, Department of surgery, university of Heidelberg
ClinicalTrials.gov Identifier: NCT01191632    
Other Study ID Numbers: S081/2008
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: October 2010
Keywords provided by Heidelberg University:
T cell
surgery
radiation
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases