Peritoneal carcinomatosis MedDRA version: 20.0 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis System Organ Class: 100000004864
Conditions
Interventions
Trade Name: doxorubicina
Product Name: Doxorubicin
Product Code: [L01DB01]
Pharmaceutical Form: Concentrate for solution for injection
CAS Number: 25316-40-9
Current Sponsor code: 25316-40-9
Other des
Sponsors
ISTITUTO ONCOLOGICO VENETO - IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 years of age - ECOG performance status 0–2. - Histologically or cytologically documented gastrointestinal or ovarian cancer (based on tissue from the primary tumor and/or its metastases); other cancer can be included based on a careful multidisciplinary assessment of the risk benefit of the procedure in the specific patient - Radiological, histological or cytological evidence of peritoneal metastases - Not eligible for curative surgery and/or HIPEC according to National Guidelines - ife expectancy of at least 24 weeks; - Laboratory Requirements: - Neutrophils = 1.5 x 109/L; - Platelets = 100 x 109/L; - Hemoglobin = 9 g/dL; - Total bilirubin = 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL; - Alkaline phosphatase = 2.5 x UNL; - Creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =1.5 x UNL; - Negative serum or urine pregnancy test at screening for women of childbearing potential. Female subjects, or male subjects with female partners of child-bearing potential must be willing to use highly effective contraception as approved by the investigator (i.e. barrier contraceptive measure or oral contraception, total abstinence) during the study and until 30 days after last study treatment; - Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure; - Will and ability to comply with the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Any surgery apart from staging laparoscopy less than 4 weeks before inclusion; - Extra peritoneal metastasis; patients with limited extra peritoneal metastatic disease can be enrolled based on mdt discussion; - Bowel obstruction or parenteral nutrition or gastric tube; - A history of allergic reaction or contraindication to platinum containing compounds or doxorubicin; - Any significant disease which, in the investigator’s opinion, excludes the patient from the study; - Myocardial insufficiency, defined as NYHA class >3 - Renal impairment, defined as glomerular filtration rate (GFR) 1.5 UNL (except in presence of Gilbert disease) - Pregnancy or breastfeeding; - Untreated central nervous system disease, history or evidence of thrombotic or hemorrhagic disorders not considered currently in complete remission; - Active infection requiring antibiotics; - Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to determine the effectiveness of PIPAC technique in patients with peritoneal metastases, who are not eligible for curative surgical resection.;Secondary Objective: Secondary aims are to determine - the feasibility of the study treatment - the safety of the PIPAC technique - the antineoplastic activity - preliminary data on progression free survival (PFS) and overall survival (OS) - the quality of life (HRQoL);Primary end point(s): The primary endpoint is the histological response to treatment, assessed using the peritoneal regression grading system (PRGS) score. Response to treatment will be assessed comparing the PRGS score at each PIPAC procedure respect to the PRGS score at the first PIPAC procedure (baseline). Patients, who did not receive at least three procedures, will be considered non responders. The PRGS score distinguishes between four grades of tumor regression, PRGS 1–4. PRGS 1 (complete response) is defined as no tumor cells present; PRGS 2 (major response) is regressive changes predominant over tumor cells; PRGS 3 (minor response) is predominance of tumor cells but regressive changes present, and PRGS 4 (no response) is no regressive changes present. At least four peritoneal punch biopsies of 3 to 5mm in diameter should be taken in all four abdominal quadrants, plus a centimetric peritonectomy of not-affected peritoneum (to be used as reference). The PRGS score will be reported as the mean and the worst value of the regression grades obtained. When complete tumor response is suspected intraoperatively, a peritoneal cytology should be sampled. A histological tumor response is defined as a decrease of 0.5 in the mean PRGS score. Tumor response rate is defined as the portion of participants with a histological tumor response.;Timepoint(s) of evaluation of this end point: At second and third PIPAC procedure after 6 or 8 weeks and 12 or 16 weeks after first PIPAC procedure. | — |
Countries
Italy
Contacts
Public ContactUnità Ricerca Clinica
Istituto Oncologico Veneto
Outcome results
None listed