Refractory Metastatic Colorectal Cancer
Conditions
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.
Interventions
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Through study completion, an average of 3 months | (≥ partial response) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression | During 3 years of trial conduction | Hospital Anxiety and Depression Scale (HADS-D) |
| Acute and late toxicity | During 3 years of trial conduction | CTCAE version 5 |
| PFS | Through study completion, an average of 6 months | Progression-free survival |
| OS | Through study completion, an average of 1 year | Overall survival |
| QoL | During 3 years of trial conduction | European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 |
Countries
Germany
Contacts
Primary ContactPirus Ghadjar, Prof. Dr.
Backup ContactMarcus Beck, Dr.
Outcome results
None listed