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

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ClinicalTrials.gov Identifier: NCT05991102
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
Pirus Ghadjar, Charite University, Berlin, Germany

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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) and Bevacizumab in Refractory Metastatic Colorectal Cancer
Actual Study Start Date : December 15, 2023
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatment

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.

 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
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Through study completion, an average of 3 months ]
    (≥ partial response)


Secondary Outcome Measures :
  1. PFS [ Time Frame: Through study completion, an average of 6 months ]
    Progression-free survival

  2. OS [ Time Frame: Through study completion, an average of 1 year ]
    Overall survival

  3. QoL [ Time Frame: During 3 years of trial conduction ]
    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

  4. QoL [ Time Frame: During 3 years of trial conduction ]
    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21

  5. Anxiety and depression [ Time Frame: During 3 years of trial conduction ]
    Hospital Anxiety and Depression Scale (HADS-D)

  6. Acute and late toxicity [ Time Frame: During 3 years of trial conduction ]
    CTCAE version 5


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05991102


Contacts
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Contact: Pirus Ghadjar, Prof. Dr. +49 30 450 527318 pirus.ghadjar@charite.de
Contact: Marcus Beck, Dr. +49 30 450 527318 marcus.beck@charite.de

Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Yvonne Saewe    +49 30 450 527318    yvonne.saewe@charite.de   
Principal Investigator: Pirus Ghadjar, Prof. Dr.         
Principal Investigator: Sebastian Stintzing, Prof. Dr.         
Sub-Investigator: Marcus Beck, Dr.         
Sub-Investigator: Alexander Hansch, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
More Information
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Responsible Party: Pirus Ghadjar, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT05991102    
Other Study ID Numbers: Live-RF
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: December 21, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases