Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2013-11-30
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
doxorubicin and cisplatin
doxorubicin and cisplatin as intraperitoneal chemotherapy
Interventions
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doxorubicin and cisplatin
doxorubicin and cisplatin as intraperitoneal chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written, informed consent
* presence of peritoneal carcinomatosis
Exclusion Criteria
* parenchymal metastases
* unability to undergo laparoscopy
18 Years
80 Years
ALL
No
Sponsors
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Ruhr University of Bochum
OTHER
Responsible Party
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Clemens Tempfer
Clemens Tempfer, MD, MBA
Principal Investigators
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Marc A Reymond, MD
Role: PRINCIPAL_INVESTIGATOR
Ruhr University of Bochum
Locations
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Ruhr University of Bochum
Herne, North Rhine-Westphalia, Germany
Countries
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References
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Struller F, Horvath P, Solass W, Weinreich FJ, Strumberg D, Kokkalis MK, Fischer I, Meisner C, Konigsrainer A, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with low-dose cisplatin and doxorubicin (PIPAC C/D) in patients with gastric cancer and peritoneal metastasis: a phase II study. Ther Adv Med Oncol. 2019 May 13;11:1758835919846402. doi: 10.1177/1758835919846402. eCollection 2019.
Other Identifiers
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PIPAC-GA01
Identifier Type: -
Identifier Source: org_study_id
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