To test if Nanosol device is efficient for peritoneal delivery of chemotherapy drugs
Phase 1
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2020/12/030030
- Lead Sponsor
- Dr Sanket Mehta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Histologically or cytologically verified peritoneal malignancy
2. No more than one extraperitoneal metastasis
3. Age >18 years
4. Written informed consent
Exclusion Criteria
1. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
2. A history of allergic reaction to platinum containing compounds or doxorubicin
3. Renal impairment , defined as glomerular filtration rate (GFR) <40 mL/min, (Cockcroft-Gault Equation)
4. Impaired liver function defined as bilirubin >= 1.5 Ã? UNL (upper normal limit)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depth of penetration and particle size estimation of the drugs produced using nanosol deviceTimepoint: follow-up at six monthly intervals post procedure
- Secondary Outcome Measures
Name Time Method Survival and quality of life post treatment with PIPAC procedureTimepoint: follow-up at six monthly intervals post procedure