Intraperitoneal Aerosol Chemotherapy in Gastric Cancer (PIPAC-GA01)
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|ClinicalTrials.gov Identifier: NCT01854255|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : November 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: doxorubicin and cisplatin||Phase 2|
Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR) of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single center, open label, non-randomized, single-arm, repeated single dose study to explore the efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and peritoneal carcinomatosis.
Target subject population:Patients with GC and PC with disease progression after at least one line of previous i.v. chemotherapy.
Investigational product, dosage and mode of administration Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and Cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied intraperitoneally as PIPAC.
Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18 weeks
1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with cisplatin and doxorubicin.
1.2 Secondary outcome variables
- The observed survival (OS)
- The median time to progression (TTP) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin
- The Peritoneal Carcinomatosis Index (PCI) before and after therapy
- The degree of histological regression assessed by pathological review
- Apoptosis as assessed by immunohistochemical analysis
- The difference in ascites volume before and after the first, second, and third PIPAC application 1.3 Patient reported outcomes (PROs)
- European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30, German version ) 1.4 Safety
- Safety and tolerability will be assessed by collection of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE) including physical examination results, laboratory assessments (chemistry and hematology).
1.5 Biological monitoring
• Basic research investigating expression of genes associated with drug resistance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Patients With Gastric Cancer and Peritoneal Carcinomatosis: an Open-label, Single-arm, Phase II Clinical Trial|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Intraperitoneal Chemotherapy
Patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4-6 weeks, applied intraperitoneally as pressurized aerosol chemotherapy. Duration of treatment will be 3 single doses in 6 weeks intervals, thus the duration of treatment is 18 weeks.
Drug: doxorubicin and cisplatin
doxorubicin and cisplatin as intraperitoneal chemotherapy
- Clinical Benefit Rate [ Time Frame: within 3 months after treatment completion ]Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.
- Observed Survival [ Time Frame: During treatment and follow-up of 1 year ]Survival will be assessed by direct observation during treatment and by follow-up investigation for 1 year after completion of the study
- median time ot progression [ Time Frame: during treatment and follow-up of 1 year ]Time to progression according to RECIST criteria during treatment and during follow-up of 1 year
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854255
|Ruhr University of Bochum|
|Herne, North Rhine Westphalia, Germany, 44625|
|Principal Investigator:||Marc A Reymond, MD||Ruhr University of Bochum|