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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05991102

Studienbeginn:
Dezember 2023

Letztes Update:
21.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Kontakt

Pirus Ghadjar, Prof. Dr.
Kontakt:
Phone: +49 30 450 527318
E-Mail: pirus.ghadjar@charite.de» Kontaktdaten anzeigen

Marcus Beck, Dr.
Kontakt:
Phone: +49 30 450 527318
E-Mail: marcus.beck@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Charité Universitätsmedizin Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yvonne Saewe
Phone: +49 30 450 527318
E-Mail: yvonne.saewe@charite.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Overall response rate (ORR) (Time Frame - Through study completion, an average of 3 months):
(≥ partial response)

Secondary outcome:

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

Geprüfte Regime

Radiofrequency electromagnetic field treatment (mEHT / capacitive hyperthermia / electrohyperthermia / ):
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Quelle: ClinicalTrials.gov

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