Intraperitoneal Aerosol Chemotherapy in Gastric Cancer
Overview[ - collapse ][ - ]
| Purpose | A prospective series of patients with recurrent gastric cancer will be treated with three cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the procedure will be assessed. |
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| Condition | Gastric Cancer |
| Intervention | Drug: doxorubicin and cisplatin |
| Phase | Phase 2 |
| Sponsor | Ruhr University of Bochum |
| Responsible Party | Ruhr University of Bochum |
| ClinicalTrials.gov Identifier | NCT01854255 |
| First Received | May 12, 2013 |
| Last Updated | November 11, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 12, 2013 |
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| Last Updated Date | November 11, 2013 |
| Start Date | November 2013 |
| Estimated Primary Completion Date | January 2016 |
| Current Primary Outcome Measures | Clinical Benefit Rate [Time Frame: within 3 months after treatment completion] [Designated as safety issue: No]Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin. |
| Current Secondary Outcome Measures | Observed Survival [Time Frame: During treatment and follow-up of 1 year] [Designated as safety issue: No]Survival will be assessed by direct observation during treatment and by follow-up investigation for 1 year after completion of the study |
Descriptive Information[ + expand ][ + ]
| Brief Title | Intraperitoneal Aerosol Chemotherapy in Gastric Cancer |
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| 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 |
| Brief Summary | A prospective series of patients with recurrent gastric cancer will be treated with three cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the procedure will be assessed. |
| Detailed Description | 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 Outcome variables: 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 |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastric Cancer |
| Intervention | Drug: doxorubicin and cisplatin doxorubicin and cisplatin as intraperitoneal chemotherapy Other Names:
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| Study Arm (s) | 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
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| Estimated Enrollment | 50 |
| Estimated Completion Date | January 2016 |
| Estimated Primary Completion Date | September 2015 |
| Eligibility Criteria | Inclusion Criteria: - age above 18 years - written, informed consent - presence of peritoneal carcinomatosis Exclusion Criteria: - language barrier - parenchymal metastases - unability to undergo laparoscopy |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Marc A Reymond, MD 02323 499 marc.reymond@marienhospital-herne.de |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01854255 |
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| Other Study ID Numbers | PIPAC-GA01 |
| Has Data Monitoring Committee | No |
| Information Provided By | Ruhr University of Bochum |
| Study Sponsor | Ruhr University of Bochum |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Marc A Reymond, MD Ruhr University of Bochum |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Ruhr University of Bochum | Herne, North Rhine Westphalia, Germany, 44625 Contact: Marc A Reymond, MD | 02323 4991478 | marc.reymond@marienhospital-herne.dePrincipal Investigator: Marc A Reymond, MD Recruiting |
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