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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

Tracking Information
First Submitted Date  ICMJE July 21, 2023
First Posted Date  ICMJE August 14, 2023
Last Update Posted Date December 21, 2023
Actual Study Start Date  ICMJE December 15, 2023
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2023)		 Overall response rate (ORR) [ Time Frame: Through study completion, an average of 3 months ]
(≥ partial response)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2023)
  • PFS [ Time Frame: Through study completion, an average of 6 months ]
    Progression-free survival
  • OS [ Time Frame: Through study completion, an average of 1 year ]
    Overall survival
  • QoL [ Time Frame: During 3 years of trial conduction ]
    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
  • QoL [ Time Frame: During 3 years of trial conduction ]
    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21
  • Anxiety and depression [ Time Frame: During 3 years of trial conduction ]
    Hospital Anxiety and Depression Scale (HADS-D)
  • Acute and late toxicity [ Time Frame: During 3 years of trial conduction ]
    CTCAE version 5
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
Official Title  ICMJE Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Metastatic Colorectal Cancer
Intervention  ICMJE Device: Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Other Names:
  • mEHT
  • capacitive hyperthermia
  • electrohyperthermia
Study Arms  ICMJE 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.

Intervention: Device: Radiofrequency electromagnetic field treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2023)		 12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2026
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05991102
Other Study ID Numbers  ICMJE Live-RF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Pirus Ghadjar, Charite University, Berlin, Germany
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Charite University, Berlin, Germany
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP