Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Tumour Specific Electroporation: Tumour Specific Electroporation Technique for patients with locally advanced or recurrent Head & Neck cancer using IQwave 3.0 CE. Patients who meet the
Sponsors
India Sweden Healthcare Innovation Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients greater than or equal to 18 years of age. 2. Any gender of the patient 3. Histologically confirmed, Recurrent or progressive locally advanced Head & Neck cancers. 4. Primary tumors do not respond to the available standard of care treatments or are exhausted from chemotherapy and radiation, and are not amenable to surgery. 5. Patients with primary tumors but medically unfit for any standard treatment 6. Patient in a physical condition suitable for general anesthesia/local anesthesia 7. A life expectancy of at least six months. 8. Patients with an ECOG performance of less than 3. 9. Signed informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients who have an extensive and rapidly progressive disease with poor performance status (ECOG > 3) and with a life expectancy of fewer than 3 months. 2. Patients with tumors seated deeper than three cm from the surface of the skin. 3. Patients who, for medical reasons, cannot be given bleomycin. 4. Patients with pre-existing pulmonary disease (COPD). 5. Patients with implanted devices such as pacemakers or insulin pumps. 6. If the tumors are located or directly attached to larger blood vessels. (Read IFU of IQwave electroporation device for more information). 7. Patients with brain metastases treated with surgery and or/radiotherapy who have progressive disease in the brain. 8. Pregnant or lactating women. 9. A prior cumulative dose of bleomycin exceeding 400 U. 10. Less than 14 days from previous cancer treatment (either local or systemic). 11. Chronic renal failure (Sr. Creatinine > 150 �µmol/L). 12. An inadequate liver function is defined as: a. AST or ALT greater than 2.5 x ULN in the absence of liver metastases or greater than 5 in the presence of liver metastases. b. Bilirubin greater than 2 x ULN (except in the case of Gilberts Syndrome) 13. Inadequate bone marrow reserve is defined as: a. White blood cell counts less than 3 x 10 /l or Neutrophil count less than 1.5 x 10/ l. 14. Patient unable, unwilling, or not in a mental stage to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate tumor size reduction after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.Timepoint: 1. 3 months 2. 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the improvement of the patientââ?¬â?¢s quality of life (QOL) and to assess the patientââ?¬â?¢s immunological response after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.Timepoint: 6 months after first treatment | — |
Countries
India
Contacts
Public ContactJeewan Ram Vishnoi
All India Institute of Medical Sciences, Jodhpur
Outcome results
None listed