Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001228976
Ethics application status
Approved
Date submitted
24/08/2020
Date registered
17/11/2020
Date last updated
17/11/2020
Date data sharing statement initially provided
17/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Proof of concept: can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) be added to standard treatment for resectable high-risk gastric cancer patients?
Scientific title
Feasibility of adding pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) to standard treatment for resectable high-risk gastric cancer patients
Secondary ID [1] 301593 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric cancer 317974 0
Condition category
Condition code
Cancer 316008 316008 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxaliplatin dose is 92 mg/m2 constituted in 150 ml dextrose.
This will be delivered via Capnopen during the procedure. This is a one time intervention.
Intervention code [1] 317896 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324211 0
The primary endpoint is for the consented 10 patients to complete the protocol with no impact on oncological surgical procedure (complications noted in operative report), surgical morbidity (hospital records during recovery period) and adhering to the gold standard FLOT pathway without delays or compromising the timelines (calendar). Formally assessed at 36 weeks, after treament envelope is complete. As this is pilot study, we will undertake a composite, pragmatic approach to assessing the primary outcome.
Hospital records will be used for assessment.
Timepoint [1] 324211 0
36 weeks.
Secondary outcome [1] 384078 0
Toxicity - blood tests, clinical review
Timepoint [1] 384078 0
Week 17

Eligibility
Key inclusion criteria
• Adult patients (> 18 years of age)
• Clinical and histopathological confirmation of gastric adenocarcinoma.
• Undergoing or recommended for curative treatment for gastric adenocarcinoma
• One or more of the following oncological high-risk features must be present:
• Positive cytology in initial peritoneal lavage
• Signet cell ring pathology
• Diffuse type gastric adenocarcinoma
• Linitis plastica as per laparoscopic, endoscopic or imaging assessment
• Proximal location
• Serosal involvement of the stomach (T3/4)
• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Extra-abdominal metastatic disease and established and proven peritoneal meatstatic disease.
• Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy
• History of allergic reaction to platinum containing compounds or doxorubicin
• Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias
• Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
• Pregnancy/breast feeding
• Any chronic medical or psychiatric condition that in the option of the investigators would make the subject unsuitable for the study or prevent compliance with study protocol procedures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables. Baseline values for demographic, clinical, and outcome variables (primary and secondary) will be tabulated for the treatment groups. These analyses will help identify potential confounding variables to be used as covariates in sensitivity analyses.
N = 10, pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
4/08/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16960 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 30620 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 306025 0
Hospital
Name [1] 306025 0
The Queen Elizabeth Hospital
Country [1] 306025 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
28 Woodville Road Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 306484 0
None
Name [1] 306484 0
Address [1] 306484 0
Country [1] 306484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306255 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 306255 0
RAH Clinical Trial Centre
1 Port Road
Adelaide SA 5000
Ethics committee country [1] 306255 0
Australia
Date submitted for ethics approval [1] 306255 0
21/08/2020
Approval date [1] 306255 0
24/09/2020
Ethics approval number [1] 306255 0

Summary
Brief summary
The purpose of this study is to determine the possibility of adding a one-time PIPAC procedure (spraying chemotherapy drug into the abdomen) to the standard treatment of gastric cancer

Who is it for?
You may be eligible for this study if you are aged 18 years or older, with diagnosis of gastric adenocarcinoma and undergoing or being recommended for the standard treatment.

Study details
Participants in this study will undergo a procedure with a camera is inserted into the abdomen to check for metastatic disease. During this procedure, chemotherapy drug will be sprayed into the abdominal cavity. The patient will spend one night in hospital for observation and be discharged home in the morning.

Participants will be expected to complete some assessments. Assessments will include clinic visits and quality of life questionnaires.

It is hoped that this research will help to determine whether patients will be able to tolerate the additional the standard of care regime without increased toxicity or a need to spend more than one extra day of time in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103254 0
Mr Markus Trochsler
Address 103254 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 103254 0
Australia
Phone 103254 0
+61882226000
Fax 103254 0
Email 103254 0
markus.trochsler@sa.gov.au
Contact person for public queries
Name 103255 0
Dr Jessica Reid
Address 103255 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 103255 0
Australia
Phone 103255 0
+61 8 82227779
Fax 103255 0
Email 103255 0
jessica.reid2@sa.gov.au
Contact person for scientific queries
Name 103256 0
Dr Jessica Reid
Address 103256 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 103256 0
Australia
Phone 103256 0
+61882226000
Fax 103256 0
Email 103256 0
jessica.reid2@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.