Intraperitoneal Aerosol Chemotherapy in Gastric Cancer
PIPAC-GA01
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
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedJuly 8, 2022
July 1, 2022
2.9 years
May 12, 2013
July 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate
Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.
within 3 months after treatment completion
Secondary Outcomes (1)
Observed Survival
During treatment and follow-up of 1 year
Other Outcomes (1)
median time ot progression
during treatment and follow-up of 1 year
Study Arms (1)
Intraperitoneal Chemotherapy
EXPERIMENTALPatients 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.
Interventions
doxorubicin and cisplatin as intraperitoneal chemotherapy
Eligibility Criteria
You may qualify if:
- age above 18 years
- written, informed consent
- presence of peritoneal carcinomatosis
You may not qualify if:
- language barrier
- parenchymal metastases
- unability to undergo laparoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruhr University of Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (1)
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.
PMID: 31205501RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc A Reymond, MD
Ruhr University of Bochum
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clemens Tempfer, MD, MBA
Study Record Dates
First Submitted
May 12, 2013
First Posted
May 15, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
July 8, 2022
Record last verified: 2022-07