Live-RF: Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05991102
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractory Metastatic Colorectal Cancer	Device: Radiofrequency electromagnetic field treatment	N/A

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 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. In addition, the patients enrolled in this trial will be compared to historic data from patients who underwent treatment with TAS-102 in this setting (RECOURSE trial).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer
• Actual Study Start Date: Jul 21, 2023
• Anticipated Primary Completion Date: May 31, 2026
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: TAS-102 and radiofrequency electromagnetic field treatment Each treatment cycle with TAS-102 will be 28 days in duration. TAS-102 treatment should be continued until progression or unacceptable toxicity. Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily Days 6 through 7: Recovery Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily Days 13 through 28: Recovery Radiofrequency electromagnetic field treatment using the EHY-2030 device starts within the first week of TAS-102 and should be performed and continued 2 times weekly (60 min each) until progression or the occurrence of unacceptable toxicity. The interval between radiofrequency electromagnetic field treatments treatments should be at least 48h. A modulated electric field with a carrier radiofrequency 13.56 MHz will be generated.

Device: Radiofrequency electromagnetic field treatment; Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz; Other Names: mEHT capacitive hyperthermia electrohyperthermia

Outcome Measures

Primary Outcome Measures

1. Overall response rate (ORR) [Through study completion, an average of 3 months]

   (≥ partial response)

Secondary Outcome Measures

1. PFS [Through study completion, an average of 6 months]

   Progression-free survival

2. OS [Through study completion, an average of 1 year]

   Overall survival

3. QoL [During 3 years of trial conduction]

   European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

4. QoL [During 3 years of trial conduction]

   European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21

5. Anxiety and depression [During 3 years of trial conduction]

   Hospital Anxiety and Depression Scale (HADS-D)

6. Acute and late toxicity [During 3 years of trial conduction]

   CTCAE version 5

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin		Germany	13353

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pirus Ghadjar, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT05991102
• Other Study ID Numbers: Live-RF
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Aug 14, 2023