Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

Refractory Metastatic Colorectal Cancer Clinical Trial

— Live-RF  

Official title:

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991102
• Other study ID #: Live-RF
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: November 2026

Study information

• Verified date: December 2023
• Source: Charite University, Berlin, Germany
• Contact: Pirus Ghadjar, Prof. Dr.
• Phone: +49 30 450 527318
• Email: pirus.ghadjar[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Refractory Metastatic Colorectal Cancer

Intervention

Device:
• Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	(= partial response)	Through study completion, an average of 3 months
Secondary	PFS	Progression-free survival	Through study completion, an average of 6 months
Secondary	OS	Overall survival	Through study completion, an average of 1 year
Secondary	QoL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	During 3 years of trial conduction
Secondary	QoL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21	During 3 years of trial conduction
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS-D)	During 3 years of trial conduction
Secondary	Acute and late toxicity	CTCAE version 5	During 3 years of trial conduction