Efficacy and Safety of PIPAC/PITAC in Gastric,Ovarian, Colorectal Cancer and Mesothelioma With Pleural Carcinomatosis.

Colorectal Cancer Clinical Trial

— PIPAC/PITAC  

Official title:

Efficacy and Safety of PIPAC/PITAC With Cisplatin and Doxorubicin in Gastric, Ovarian and Colorectal Cancer With Peritoneal Carcinomatosis and Oxaliplatin in Patients With Mesothelioma/Pleural Cancer With Pleural Carcinomatosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02720835
• Other study ID #: Visz-001-2016
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: September 8, 2016
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: Klinik Hirslanden, Zurich
• Contact: Othmar Schoeb, MD, PhD
• Phone: +41 44 387 3700
• Email: os[@]professorschoeb.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Outcome measurement for patients with gastric, ovarian, colorectal, or pleural cancer/mesothelioma with peritoneal/pleural carcinomatosis undergoing pressurized intraperitoneal/intrathoracal aerosol chemotherapy (PIPAC/PITAC) with cisplatin and doxorubicin or oxaliplatin. Record of (partial/total) tumor response rate via survival rate, time until tumor progression (according to RECIST-criteria), peritoneal carcinomatosis index (PCI) before and after therapy, histological tumor progression/regression, ascites/pleural affusion volume, degree of tumor cell apoptosis.

Description:

Outcome data for 200 patients (50 patients each of with gastric, ovarian, colorectal, or pleural cancer/mesothelioma with peritoneal/pleural carcinomatosis) undergoing pressurized intraperitoneal/intrathoracal aerosol chemotherapy (PIPAC/PITAC) with cisplatin and doxorubicin or oxaliplatin.

The indication depends on the tumor entity and spread, the previous chemotherapeutic therapy and the patient's condition. If these are matched and the indication for PIPAC/PITAC therapy is provided by a multidisciplinary Tumorboard, the patient will be offered to undergo PIPAC/PITAC therapy. Despite PIPAC/PITAC therapy entails an off label use of the chemotherapeutic agents, health insurance covers the treatment for carefully selected patients after special approval. With this observational study, the Klinik Hirslanden aims at monitoring treated patients and to evaluate the safety and efficacy properties of PIPAC/PITAC treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age > 18 years Provided indication for PIPAC/PITAC Informed consent

Exclusion Criteria:

Patient unable to communicate Refusal of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Mesothelioma
• Ovarian Cancer
• Stomach Neoplasms

Intervention

Procedure:
• pressurized intraperitoneal/intrathoracal aerosol chemoTx
The first PIPAC/PITAC procedures are performed in an operating room equipped with laminar air-flow and is remote controlled. A nebulizer is connected to a high-pressure injector and inserted into the abdominal cavity through a trocar. For PITAC, two trocars are inserted into the thoracic cavity. Then, a pressurized aerosol containing the chemotherapeutic agent is applied. The system is kept in steady-state for 30 min for application. Toxic aerosol is disposed via a closed system and trocars are retracted. The procedure is repeated two to five times at various time intervals.

Locations

Country	Name	City	State
Switzerland	HIRSLANDEN Klinik Hirslanden	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Othmar Schoeb

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC/PITAC		2 years	No
Secondary	Peritoneal carcinomatosis index (PCI)		2 years	No
Secondary	Histological tumor regression/progression		2 years	No
Secondary	Time until tumor progression (months, clinical investigations)		2 years	No
Secondary	Ascites/pleural affusion volume (ml, clinical investigation)		2 years	No
Secondary	Degree of tumor cell apoptosis (apoptosis index, histological examination)		2 years	No
Secondary	Overall survival (months, clinical investigations)		2 years	No