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Trial Title:
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
NCT ID:
NCT05991102
Condition:
Refractory Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Radiofrequency electromagnetic field treatment
Description:
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Arm group label:
TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment
Other name:
mEHT
Other name:
capacitive hyperthermia
Other name:
electrohyperthermia
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- Knowledge of KRAS status (i.e. wild-type or mutant)
- Adequate bone-marrow, liver and renal function:
1. Hemoglobin value of ≥9.0 g/dL.
2. Absolute neutrophil count of ≥1,500/mm3
3. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).
4. Total serum bilirubin of ≤1.5 mg/dL
5. 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.
6. 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
Exclusion Criteria:
- Significant extrahepatic metastasis
- Previous treatment with TAS 102
- Serious illness other than colorectal cancer or serious medical condition:
1. Other concurrently active malignancies excluding malignancies that are disease
free for more than 5 years or carcinoma-in-situ deemed cured by adequate
treatment.
2. Known brain metastasis or leptomeningeal metastasis.
3. Active infection (ie, body temperature ≥38°C due to infection).
4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4
weeks
5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or
cerebrovascular disorder
6. Uncontrolled diabetes.
7. Myocardial infarction within the last 12 months, severe/unstable angina,
symptomatic congestive heart failure New York Heart Association (NYHA III/IV)
8. Gastrointestinal hemorrhage.
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness, or hepatitis B or C.
10. Patients with autoimmune disorders or history of organ transplantation who
require immunosuppressive therapy.
11. 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Yvonne Saewe
Phone:
+49 30 450 527318
Email:
yvonne.saewe@charite.de
Investigator:
Last name:
Pirus Ghadjar, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Sebastian Stintzing, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Marcus Beck, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Alexander Hansch, Dr.
Email:
Sub-Investigator
Start date:
December 15, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991102
