Refractory Metastatic Colorectal CancerLive-RFNCT05991102
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
A study testing Radiofrequency electromagnetic field treatment in people with Refractory Metastatic Colorectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Metastatic Colorectal Cancer
- What is being tested?
- Radiofrequency electromagnetic field treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to any study procedure
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed colorectal cancer
- Liver metastasis
- Patients received at least two prior regimens of standard chemotherapies and the patient is refractory to or failing these therapies or is unsuitable for the treatment.Standard chemotherapy includes fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and for patients with KRAS wild-type tumors at least one anti-EGFR monoclonal antibody of cetuximab/panitumumab. Patients with BRAF mutant tumors: BRAF inhibitor, MSI-H patients: Checkpoint-inhibition
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- Knowledge of KRAS status (i.e. wild-type or mutant)
- Adequate bone-marrow, liver and renal function:
- Hemoglobin value of ≥9.0 g/dL.
- Absolute neutrophil count of ≥1,500/mm3
- Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).
- Total serum bilirubin of ≤1.5 mg/dL
- Aspartate aminotransferase and alanine aminotransferase
- ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying Liver metastasis, AST and ALT ≤5 × ULN.
- Serum creatinine of ≤1.5 mg/dL.
- Patient is able to take medications orally
- Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
Who cannot join
- Significant extrahepatic metastasis
- Previous treatment with TAS 102
- Serious illness other than colorectal cancer or serious medical condition:
- Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
- Known brain metastasis or leptomeningeal metastasis.
- Active infection (ie, body temperature ≥38°C due to infection).
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- Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks
- Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder
- Uncontrolled diabetes.
- Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA III/IV)
- Gastrointestinal hemorrhage.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
- Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
- Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
- Radiofrequency treatment technically not possible (e.g. larger metal implants)
- Cardiac pacemakers/ICD
- Patient not able for supine positioning (e.g. due to pain)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Yvonne Saewe, +49 30 450 527318, yvonne.saewe@charite.de
Pirus Ghadjar, Prof. Dr.
About this study
Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer
Read the detailed description
Charité Universitätsmedizin Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is only data available regarding the low toxicity profile of radiofrequency electromagnetic field treatment for various regions of the body including the abdomen there is no data available on the combined effect of TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Being tested
- Radiofrequency electromagnetic field treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency electromagnetic field treatmentDevice
Also called mEHT, capacitive hyperthermia, electrohyperthermia
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment | Experimental | Each treatment cycle with TAS-102 will be 28 days in duration.
One treatment cycle consists of the following:
* Days 1: Bevacizumab (5 mg/m2/dose) intravenous.
* Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.
* Days 6 through 7: Recovery
* Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
* Days 13 through 28: Recovery
* Days 15: Bevacizumab (5 mg/m2/dose) intravenously.
Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of systemic therapy 2 times weekly (60 min each) with an interval of at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated. Receives: Device: Radiofrequency electromagnetic field treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
(≥ partial response)
Measured: Through study completion, an average of 3 months
Secondary outcomes (6)
PFS
Progression-free survival
Measured: Through study completion, an average of 6 months
OS
Overall survival
Measured: Through study completion, an average of 1 year
QoL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: During 3 years of trial conduction
QoL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21
Measured: During 3 years of trial conduction
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS-D)
Measured: During 3 years of trial conduction
Acute and late toxicity
CTCAE version 5
Measured: During 3 years of trial conduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Dec 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirus Ghadjar, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991102
- Sponsor's protocol ID
- Live-RF
- Acronym
- Live-RF
- Status last verified
- Dec 2023
- First submitted
- 21 Jul 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05991102
- Acronym / sponsor ID
- Live-RF / Live-RF
- Conditions
- Refractory Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- 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.
Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer
Detailed description
Charité Universitätsmedizin Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is only data available regarding the low toxicity profile of radiofrequency electromagnetic field treatment for various regions of the body including the abdomen there is no data available on the combined effect of TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment | Experimental | Device: Radiofrequency electromagnetic field treatmentEach treatment cycle with TAS-102 will be 28 days in duration. One treatment cycle consists of the following: * Days 1: Bevacizumab (5 mg/m2/dose) intravenous. * Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. * Days 6 through 7: Recovery * Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. * Days 13 through 28: Recovery * Days 15: Bevacizumab (5 mg/m2/dose) intravenously. Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of systemic therapy 2 times weekly (60 min each) with an interval of at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written informed consent prior to any study procedure
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically confirmed colorectal cancer
- Liver metastasis
Key exclusion criteria (17 listed)
- Significant extrahepatic metastasis
- Previous treatment with TAS 102
- Serious illness other than colorectal cancer or serious medical condition:
- Radiofrequency treatment technically not possible (e.g. larger metal implants)
- Cardiac pacemakers/ICD
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 |
|---|---|---|
| Radiofrequency electromagnetic field treatmentAlso: mEHT, capacitive hyperthermia, electrohyperthermiaRadiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz | Device | TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment |
Primary outcome
Overall response rate (ORR)
Time frame: Through study completion, an average of 3 months
(≥ partial response)
6 secondary outcomes
PFS
Time frame: Through study completion, an average of 6 months
OS
Time frame: Through study completion, an average of 1 year
QoL
Time frame: During 3 years of trial conduction
QoL
Time frame: During 3 years of trial conduction
Anxiety and depression
Time frame: During 3 years of trial conduction
Acute and late toxicity
Time frame: During 3 years of trial conduction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency electromagnetic field treatment in people with Refractory Metastatic Colorectal Cancer, run by Charite University, Berlin, Germany 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 17 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Dec 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pirus Ghadjar, Prof. Dr. (+49 30 450 527318, pirus.ghadjar@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2023.