Colorectal Liver MetastasesPhase 1/2NCT01191632
Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
A Phase 1/2 study testing one time radiation and No Radiation in people with Colorectal Liver Metastases, run by Heidelberg University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- one time radiation and No Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Mar 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, 69120
Juergen Weitz, +49 6221 56 6250, juergen.weitz@med.uni-heidelberg.de
Christoph Reissfelder, +49 6221 56 6250, christoph.reissfelder@med.uni-heidelberg.de
About this study
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
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.
- Conditions
- Colorectal Liver Metastases
- Being tested
- one time radiation, No Radiation
- Keywords
- T cell, surgery, radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
No RadiationRadiation
Control group with 0Gy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: one time radiation |
| No radiation | Active comparator | Control group with 0Gy radiation Receives: 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 Receives: 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 Receives: Radiation: one time radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (10)
To determine local control and recurrence patterns of colorectal liver metastases in a CT
Measured: 2 years
To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
Measured: 2 years
• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
Measured: 2 years
• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
Measured: 2 years
• To determine the T-cell activity in the resected liver tissue
Measured: 2 years
• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
Measured: 6 months
To determine the number of regulatory T-cells in the resected liver tissue
Measured: 2 years
To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
Measured: 2 years
To determine quality of life according to the EORTC QoL questionnaire after 12 months.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191632
- Sponsor's protocol ID
- S081/2008
- Status last verified
- Oct 2010
- First submitted
- 20 Aug 2010
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21961577
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01191632
- Acronym / sponsor ID
- S081/2008
- Conditions
- Colorectal Liver Metastases
- Keywords
- T cell, surgery, radiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radiation 0,5Gy | Active comparator | Radiation: one time radiationRadiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery |
| No radiation | Active comparator | Radiation: No RadiationControl group with 0Gy radiation |
| Radiation 2Gy | Active comparator | Radiation: one time radiationRadiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery |
| Radiation 5Gy | Active comparator | Radiation: one time radiationRadiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one time radiationRadiation: 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 | Radiation 0,5Gy, Radiation 2Gy, Radiation 5Gy |
| No RadiationControl group with 0Gy | Radiation | No radiation |
Primary outcome
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
10 secondary outcomes
To determine local control and recurrence patterns of colorectal liver metastases in a CT
Time frame: 2 years
To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
Time frame: 2 years
• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
Time frame: 2 years
• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
Time frame: 2 years
• To determine the T-cell activity in the resected liver tissue
Time frame: 2 years
• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
Time frame: 6 months
To determine the number of regulatory T-cells in the resected liver tissue
Time frame: 2 years
To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
Time frame: 2 years
To determine quality of life according to the EORTC QoL questionnaire after 12 months.
Time frame: 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
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
- Derived from this study: PubMed 21961577Reissfelder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing one time radiation and No Radiation in people with Colorectal Liver Metastases, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juergen Weitz, MD (+49 6221 56 6250, juergen.weitz@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.