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

ConditionRefractory Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

Combined chemotherapy and radiofrequency electromagnetic field treatment for patients with liver dominant refractory metastatic colorectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Significant extrahepatic metastasis

Previous treatment with TAS 102

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiofrequency electromagnetic field treatment

    Device

    Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: TAS-102 and Bevacizumab and radiofrequency electromagnetic field treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

(≥ partial response)

Time frame
Through study completion, an average of 3 months

Secondary outcomes

1

PFS

Progression-free survival

Time frame
Through study completion, an average of 6 months
2

OS

Overall survival

Time frame
Through study completion, an average of 1 year
3

QoL

European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

Time frame
During 3 years of trial conduction
4

QoL

European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LMC21

Time frame
During 3 years of trial conduction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Source ClinicalTrials.gov
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