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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Metastatic Colorectal Cancer | Device: Radiofrequency electromagnetic field treatment | Not Applicable |
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 |
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:
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:
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- Overall response rate (ORR) [ Time Frame: Through study completion, an average of 3 months ](≥ partial response)
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
- 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
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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)
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
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 |
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. |
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 |
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 |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |