Clinical trial NCT05991102: Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
Official title: Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Metastatic Colorectal Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: PFS
timeFrame: Through study completion, an average of 6 months
measure: OS
timeFrame: Through study completion, an average of 1 year
measure: QoL
timeFrame: During 3 years of trial conduction
measure: QoL
timeFrame: During 3 years of trial conduction
measure: Anxiety and depression
timeFrame: During 3 years of trial conduction
measure: Acute and late toxicity
timeFrame: During 3 years of trial conduction
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
References: