Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000269831
Ethics application status
Approved
Date submitted
7/12/2020
Date registered
11/03/2021
Date last updated
4/11/2022
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer.
Scientific title
The safety of hyperthermic and normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial ovarian, fallopian tube and primary peritoneal cancer (HYNOVA).
Secondary ID [1] 302946 0
CTC 0302
Secondary ID [2] 303144 0
ANZGOG 1901 /2020
Universal Trial Number (UTN)
Trial acronym
HYNOVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 319979 0
Fallopian tube cancer 320844 0
Primary peritoneal cancer 320845 0
Condition category
Condition code
Cancer 317910 317910 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental arm of normothermic intraperitoneal chemotherapy will receive cisplatin 100mg/m^2 chemotherapy given to the abdominal cavity through a catheter for 90 minutes during surgery heated at normal body temperature (37°C).
Intervention code [1] 319238 0
Treatment: Drugs
Comparator / control treatment
Participants in the comparator arm of hyperthermic intraperitoneal chemotherapy will receive cisplatin 100mg/m^2 chemotherapy given to the abdominal cavity through a catheter for 90 minutes during surgery heated to (42°C).
Control group
Active

Outcomes
Primary outcome [1] 325924 0
Proportion of patients experiencing any adverse events greater than or equal to grade 3 (CTCAE v5.0 and Clavien-Dindo classification) e.g. nausea and vomiting.
Timepoint [1] 325924 0
Within 90 days post-surgery
Secondary outcome [1] 389527 0
Frequency of adverse events of interest using CTCAE v5.0 and Clavien-Dindo classification for surgical adverse events
Timepoint [1] 389527 0
Duration of trial
Secondary outcome [2] 389528 0
Surgical morbidity by collecting data from hospital and surgical records (eg length of intensive care unit (ICU) stay, readmission to ICU, duration of vasopressor use, intra-operative and post-operative blood transfusion, length of hospital stay)
Timepoint [2] 389528 0
Within 90 days post-surgery
Secondary outcome [3] 389529 0
Health Related Quality of Life
Timepoint [3] 389529 0
At 24 months post randomisation
Secondary outcome [4] 389530 0
Resource utilisation. Hospitalisation information will be collected for all patients. Major components include days in intensive care units and days in hospital, returns to operating theatre, emergency room visits, and the number of days of total parenteral nutrition (TPN).
Timepoint [4] 389530 0
Duration of the trial
Secondary outcome [5] 389531 0
Feasibility of NIPEC. The proportion of patients that correctly received their randomised treatment and the proportion of patients that received all 6 cycles of chemotherapy will be collected in study database.
Timepoint [5] 389531 0
After patients receive their randomised treatment and the proportion of patients that received all 6 cycles of chemotherapy.
Secondary outcome [6] 389532 0
Progression free survival. Progression free survival will be determined by GCIG criteria in combination with clinical and/or radiological assessments.
Timepoint [6] 389532 0
From randomisation until the date of first evidence of progression of disease. Progression free survival is defined as the time from randomisation until the date of first evidence of progression of disease or death due to any cause, whichever comes first.
Secondary outcome [7] 389533 0
Overall survival
Timepoint [7] 389533 0
From the date of randomisation to date of death from any cause.

Eligibility
Key inclusion criteria
1. Age 18 -75 years
2. Participants diagnosed with primary FIGO stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity.
3. Histopathology must be high grade serous, endometroid (grade 2 and 3), clear cell adenocarcinoma or mixed high grade histologies.
4. Have 3-4 cycles of pre-operative platinum-based chemotherapy
5. No progression of disease on radiological imaging and/or Ca125 during neoadjuvant chemotherapy
6. ECOG performance status 0 or 1
7. Fit for surgery as determined by study surgical team
9. Adequate bone marrow function.
10. Adequate liver function
11. Adequate renal function
12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
13. Signed, written informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with extra-abdominal disease.
2. Participants with intrahepatic or other visceral metastasis detected on radiological imaging which is not surgically resectable at diagnosis and/or after pre-operative chemotherapy treatment.
3. Any contraindications to receiving intraperitoneal cisplatin chemotherapy as per the treating medical oncologist such as drug allergy.
4. Had received bevacizumab in combination with neo-adjuvant chemotherapy treatment
5. Serious medical or psychiatric conditions that may prevent compliance with the protocol or that may compromise assessment of key outcomes
6. History of another malignancy within 5 years prior to registration. Participants with curatively treated cervical carcinoma in situ or non-melanomatous carcinoma of the skin, or participants who have been free of other malignancies for greater than or equal to 5 years prior to registration are eligible for this study
7. Concurrent illness, including active intra-abdominal sepsis that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety as determined by the study surgical team.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
24/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 23499 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 23500 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 23501 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 38907 0
2050 - Camperdown
Recruitment postcode(s) [2] 38908 0
3000 - Melbourne
Recruitment postcode(s) [3] 38909 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307368 0
Government body
Name [1] 307368 0
Australian Government - Medical Research Future Fund (MRFF)
Country [1] 307368 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney, Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 308022 0
None
Name [1] 308022 0
Address [1] 308022 0
Country [1] 308022 0
Other collaborator category [1] 281564 0
Other Collaborative groups
Name [1] 281564 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [1] 281564 0
Level 6, Chris O’Brien Lifehouse
119-143 Missenden Road,
Camperdown, NSW 2050
Country [1] 281564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307456 0
Sydney Local Health District (SLHD) - RPA Zone Research Ethics and Governance
Ethics committee address [1] 307456 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
Camperdown, NSW 2050
Ethics committee country [1] 307456 0
Australia
Date submitted for ethics approval [1] 307456 0
24/11/2020
Approval date [1] 307456 0
19/03/2021
Ethics approval number [1] 307456 0

Summary
Brief summary
This study is investigating the safety of administering heated (42 degrees Celsius) versus normal temperature (37 degrees Celsius) chemotherapy during surgery for ovarian cancer patients.

Who is it for?
You may be eligible for this trial if you are a female aged 18-75 years who has been diagnosed with primary stage III epithelial ovarian, fallopian tube or peritoneal cancer with disease that is limited to the abdominal cavity. You must have had 3-4 cycles of pre-operative platinum-based chemotherapy and be fit for surgery.

Study details
Participants will receive cisplatin chemotherapy administered intraperitoneally to the abdominal cavity during surgery. They will randomly be allocated to either a hyperthermic arm, who will receive the chemotherapy drug heated to 42 degrees Celsius, or a normothermic arm who will receive the drug at normal body temperature of 37 degrees Celsius. Follow-up information about adverse events, quality of life and disease outcomes will be collected following the surgery.

Information from this study will be used to design future trials evaluating the efficacy of heated chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107294 0
A/Prof Rhonda Farrell
Address 107294 0
NHMRC Clinical Trials Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 107294 0
Australia
Phone 107294 0
+61 2 8036 5262
Fax 107294 0
Email 107294 0
[email protected]
Contact person for public queries
Name 107295 0
Ms HYNOVA Trial Operations Coordinator
Address 107295 0
NHMRC Clinical Trials Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 107295 0
Australia
Phone 107295 0
+61 2 9562 5000
Fax 107295 0
Email 107295 0
[email protected]
Contact person for scientific queries
Name 107296 0
Ms HYNOVA Trial Operations Coordinator
Address 107296 0
NHMRC Clinical Trials Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 107296 0
Australia
Phone 107296 0
+61 2 9562 5000
Fax 107296 0
Email 107296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently no plan and participant informed consent will be required.


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
SourceTitleYear of PublicationDOI
EmbaseClinical trial protocol for HyNOVA: Hyperthermic and normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage iii epithelial ovarian, fallopian tube and primary peritoneal cancer (ANZGOG1901/2020).2022https://dx.doi.org/10.3802/JGO.2022.33.E1
N.B. These documents automatically identified may not have been verified by the study sponsor.