CTRI/2022/09/045315
Not yet recruiting
Phase 2
A Clinical Applicability Study of the Tumour Specific Electroporation Technique for Patients with Locally Advanced or Recurrent Head & Neck Cancer Using IQwave 3.0 CE.
India Sweden Healthcare Innovation Centre0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Sponsor
- India Sweden Healthcare Innovation Centre
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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).
Outcomes
Primary Outcomes
Not specified
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