NCT01191632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

August 20, 2010

Last Update Submit

October 21, 2010

Conditions

Colorectal Liver Metastases

Keywords

T cellsurgeryradiation

Outcome Measures

Primary Outcomes (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

    2 years

Secondary Outcomes (10)

  • To determine local control and recurrence patterns of colorectal liver metastases in a CT

    2 years

  • 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

  • +5 more secondary outcomes

Study Arms (4)

Radiation 0,5Gy

ACTIVE COMPARATOR

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

No radiation

ACTIVE COMPARATOR

Control group with 0Gy radiation

Radiation: No Radiation

Radiation 2Gy

ACTIVE COMPARATOR

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 5Gy

ACTIVE COMPARATOR

Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery

Radiation: one time radiation

Interventions

one time radiationRADIATION

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

Radiation 0,5GyRadiation 2GyRadiation 5Gy
No RadiationRADIATION

Control group with 0Gy

No radiation

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • second malignancy
  • Pregnancy and lactation
  • no prior liver radiation
  • liver metastasis must be resectable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

  • Reissfelder C, Timke C, Schmitz-Winnenthal H, Rahbari NN, Koch M, Klug F, Roeder F, Edler L, Debus J, Buchler MW, Beckhove P, Huber PE, Weitz J. A randomized controlled trial to investigate the influence of low dose radiotherapy on immune stimulatory effects in liver metastases of colorectal cancer. BMC Cancer. 2011 Sep 30;11:419. doi: 10.1186/1471-2407-11-419.

    PMID: 21961577DERIVED

Central Study Contacts

Juergen Weitz, MD

CONTACT

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

Christoph Reissfelder, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 31, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 22, 2010

Record last verified: 2010-10

Locations

DE(1)