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Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors - PI-CaP

Studio Clinico

Patologia: Tumori dell’ovaio, Neoplasie dello stomaco, Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: I, II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
- Patients aged between 18 and 78 years.
- Performance status sec. ECOG ≤ 2
- Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
- Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
- Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
- Written informed consent.
- Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.

Criteri di esclusione: 

- Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
- Bowel obstruction.
- Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
- Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
- Creatinine clearance < 60 ml /min.
- Pregnancy.
- Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones.
- Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
- Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and the following 6 months after the last treatment

Trattamento sperimentale: 

Cohort A (for patients that have indication for systemic therapy with standard chemotherapy): Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose (this cohort has a Phase II design)
Cohort B (for patients that have not indication for systemic therapy with standard chemotherapy): Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose (this cohort has a phase I design)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC. [Time Frame: 18 weeks]

Obiettivi secondari dello studio: 

- The overall survival (OS) [Time Frame: 30 months]
- The degree of histological regression assessed by pathological review [Time Frame: 18 weeks]
- The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC [Time Frame: 30 months]
- Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0). [Time Frame: 22 weeks]
- The Peritoneal Carcinomatosis Index (PCI) before and after therapy [Time Frame: 18 weeks]

Note generali: 

Durante il trattamento vengono effettuate biopsie

Centri partecipanti

Nord Italia

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Riferimento: Dr. Michele De Simone
Telefono: 0119933673
Email: michele.desimone@ircc.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02604784

Data di inserimento: 20.12.2018

Promotore

Fondazione del Piemonte per l'Oncologia

CRO

/

Principal Investigator ITALIA

Fondazione del Piemonte per l'Oncologia - I.R.C.C.S. Candiolo

Riferimento: Dr. Michele De Simone

Telefono: 0119933673

Email: michele.desimone@ircc.it

Localita: Candiolo (To)

 

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