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

Primary Purpose

Refractory Metastatic Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radiofrequency electromagnetic field treatment
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Hemoglobin value of ≥9.0 g/dL. Absolute neutrophil count of ≥1,500/mm3 Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L). Total serum bilirubin of ≤1.5 mg/dL 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. 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: Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. Known brain metastasis or leptomeningeal metastasis. Active infection (ie, body temperature ≥38°C due to infection). Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder Uncontrolled diabetes. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA III/IV) Gastrointestinal hemorrhage. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy. 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)

Sites / Locations

  • Charité Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAS-102 and radiofrequency electromagnetic field treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall response rate (ORR)
(≥ partial response)

Secondary Outcome Measures

PFS
Progression-free survival
OS
Overall survival
QoL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
QoL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS-D)
Acute and late toxicity
CTCAE version 5

Full Information

First Posted
July 21, 2023
Last Updated
August 3, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05991102
Brief Title
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer
Acronym
Live-RF
Official Title
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) in Refractory Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAS-102 and radiofrequency electromagnetic field treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency electromagnetic field treatment
Other Intervention Name(s)
mEHT, capacitive hyperthermia, electrohyperthermia
Intervention Description
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
(≥ partial response)
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
Through study completion, an average of 6 months
Title
OS
Description
Overall survival
Time Frame
Through study completion, an average of 1 year
Title
QoL
Description
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time Frame
During 3 years of trial conduction
Title
QoL
Description
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21
Time Frame
During 3 years of trial conduction
Title
Anxiety and depression
Description
Hospital Anxiety and Depression Scale (HADS-D)
Time Frame
During 3 years of trial conduction
Title
Acute and late toxicity
Description
CTCAE version 5
Time Frame
During 3 years of trial conduction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Hemoglobin value of ≥9.0 g/dL. Absolute neutrophil count of ≥1,500/mm3 Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L). Total serum bilirubin of ≤1.5 mg/dL 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. 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: Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. Known brain metastasis or leptomeningeal metastasis. Active infection (ie, body temperature ≥38°C due to infection). Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder Uncontrolled diabetes. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA III/IV) Gastrointestinal hemorrhage. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pirus Ghadjar, Prof. Dr.
Phone
+49 30 450 527318
Email
pirus.ghadjar@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Beck, Dr.
Phone
+49 30 450 527318
Email
marcus.beck@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Saewe
Phone
+49 30 450 527318
Email
yvonne.saewe@charite.de
First Name & Middle Initial & Last Name & Degree
Pirus Ghadjar, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Sebastian Stintzing, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Marcus Beck, Dr.
First Name & Middle Initial & Last Name & Degree
Alexander Hansch, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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