A clinical study to assess the Feasibility Study of the Tumour Specific Electroporation (TSE) Technique in Patients with Locally Advanced or Recurrent Head & Neck Cancer
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/09/045315
- Lead Sponsor
- India Sweden Healthcare Innovation Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate tumor size reduction after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.Timepoint: 1. 3 months <br/ ><br>2. 6 months
- Secondary Outcome Measures
Name Time Method To measure the improvement of the patient�s quality of life (QOL) and to assess the patient�s immunological response after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.Timepoint: 6 months after first treatment