Peritoneal Carcinosis MedDRA version: 9.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name:
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Will be elegible for this study all that patient affected by PC and by all this following pathologies:  Pseudomixoma peritonei  Peritoneal mesothelioma  Resecable PC from ovarian carcinoma  Resecable PC from colorectal carcinoma  Resecable PC from appendix carcinoma  Resecable PC from gastric carcinoma Since the rationale of the use of CCR in PC must be considered as the complete excision of the neoplastic implants with the eventual micro-residual not bigger than 2.5 mm. (the optimal target of CHIP). The first elegibility criteria is that preoperative work-up (CT scan, PET, diagnostic laparoscopy) has picked out all that patients who could obtain a CC-0 (no residual pathology) or CC-1 (residual pathology =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: Impossibility of an adequate follow-up Other concomitant malignant neoplastic disease Active infection or other clinical condition that could interfere on the patient?s capacity to receive the proposed treatement according to the protocol M2 Complete intestinal obstruction Inadequate renal, epatic and bone marrow fun
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the efficacy of the CCR associated with CHIP in patients with PC from primary or secondary peritoneal neoplastic desease. The study is structured like a phase II study with the aim to define the therapeutic answer and its impact on the evolution of peritoneal desease in patient with PC. With therapeutic answer we mean the percentage of the activity of the CCR associated with CHIP.;Secondary Objective: Surgical procedure of peritonectomy associated with hypertermic intraperitoneal perfusion of chemoterapic are widely described in litterature. However it?s to be underlined that only one of the chemoterapics used in this study (mythomicin) are indicated for the endoaddominal somministration. Particolar attention will be placed on individualization of the limits of this methodology to underlie morby-mortality.;Primary end point(s): the percentage of the activity of the CCR associated with CHIP. | — |
Countries
Italy
Outcome results
None listed