Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001017213
Ethics application status
Approved
Date submitted
7/06/2018
Date registered
18/06/2018
Date last updated
21/08/2020
Date data sharing statement initially provided
21/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
Scientific title
The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
Secondary ID [1] 295129 0
nil
Universal Trial Number (UTN)
Trial acronym
PIPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Metastases 308221 0
Condition category
Condition code
Cancer 307248 307248 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PIPAC is a novel therapeutic approach that is minimally invasive, does not require cytoreduction (laparotomy) and can be frequently repeated. PIPAC entails accessing the abdominal cavity using standard laparoscopic techniques with the chemotherapeutics aerosolized via a high-pressure micro-injection pump.

Oxaliplatin (or other standard of care chemotherapy as per Investigator) will be administered at 92 mg/m2 constituted in 150 ml dextrose.
Each patient will undergo three cycles, six weeks apart.
Injection parameters are a flow of 30mL/min and a maximum upstream pressure of 200 psi.
This intervention replaces systemic chemotherapy or palliative chemotherapy.



Intervention code [1] 301457 0
Treatment: Devices
Comparator / control treatment
Systemic chemotherapy
Palliative Care
Control group
Historical

Outcomes
Primary outcome [1] 306203 0
Safety - acceptable morbidity (CTCAE/Clavien-Dindo) and mortality
Timepoint [1] 306203 0
At the end of 3 cycles of treatment
Secondary outcome [1] 347870 0
Feasibility - ability to administer treatment
Timepoint [1] 347870 0
At the end of three cycles
Secondary outcome [2] 348245 0
Tumour size as assessed by imaging at Investigator discretion (RECIST)
Timepoint [2] 348245 0
At the end of three cycles of treatment

Eligibility
Key inclusion criteria
• Adult patients (> 18 years of age)
• Clinical confirmation of peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer.
• Previous histopathological evidence of neoplastic disease is available.
• Patients must have demonstrated resistance to or lack of response to already approved and available systemic chemotherapy.
• 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, excluding low volume lung metastasis.
• Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy
• Chemotherapy, radiotherapy or surgery within the last 4 weeks prior to dosing
• 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
• Large volume ascites (greater than one litre).
• Pregnancy
• 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
Treatment
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/12/2019
Actual
20/05/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
2/08/2020
Actual
Sample size
Target
112
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11104 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 22917 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 299721 0
Hospital
Name [1] 299721 0
Department of Surgery, University of Adelaide, TQEH
Country [1] 299721 0
Australia
Primary sponsor type
Hospital
Name
Department of Surgery, University of Adelaide, TQEH
Address
Level 6A
Department of Surgery, University of Adelaide
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country
Australia
Secondary sponsor category [1] 299055 0
None
Name [1] 299055 0
Address [1] 299055 0
Country [1] 299055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300610 0
Central Adelaide Local Health Network Human Research Ethics Committee [EC00192]
Ethics committee address [1] 300610 0
CALHN Research Office
c/o RAH Clinical Trials Centre
Level 3, 3D460.02
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Ethics committee country [1] 300610 0
Australia
Date submitted for ethics approval [1] 300610 0
11/06/2018
Approval date [1] 300610 0
06/09/2018
Ethics approval number [1] 300610 0

Summary
Brief summary
The aim of this study is to assess feasibility, tumour response, adverse events, and quality of life of aerosolised chemotherapy in peritoneal cancer/s

Who is it for?
You may be eligible for this study if you are ages 18 or above and have clinical confirmation of unresectable peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer

Study details
This study is for patients who have unresectable peritoneal metastases and have not responded to standard systemic chemotherapy. All eligible patients will receive the intervention. In a operating theatre, your belly/abdomen will have chemotherapy pumped directly into it.
This study will involve blood tests, imaging, questionnaires and physical examinations.

It is hoped this research will demonstrate the safety and effectiveness of this technique in the management of peritoneal metastases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84210 0
Prof Peter Hewett
Address 84210 0
Level 6A
Department of Surgery, University of Adelaide, TQEH
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 84210 0
Australia
Phone 84210 0
+61 8 8 222 6000
Fax 84210 0
Email 84210 0
peter.hewett@sa.gov.au
Contact person for public queries
Name 84211 0
Dr Jessica Reid
Address 84211 0
Level 6A
Department of Surgery, University of Adelaide, TQEH
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 84211 0
Australia
Phone 84211 0
+61 8 8 222 7779
Fax 84211 0
Email 84211 0
jessica.reid2@sa.gov.au
Contact person for scientific queries
Name 84212 0
Prof Peter Hewett
Address 84212 0
Level 6A
Department of Surgery, University of Adelaide, TQEH
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Country 84212 0
Australia
Phone 84212 0
+61 8 8 222 6000
Fax 84212 0
Email 84212 0
peter.hewett@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.