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Trial registered on ANZCTR


Registration number
ACTRN12624001230549p
Ethics application status
Not yet submitted
Date submitted
17/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PREDICTORG: A Multicentre Personalised Medicine Approach in the Treatment of Colorectal Peritoneal Metastases
Scientific title
An assessment of cancer outcomes post cytoreductive surgery and intraperitoneal chemotherapy for colorectal peritoneal metastases with the use of a personalised aproach to choice of intraperitoneal chemotherapy agent individualised to a patient's specific tumour sensitivity in-vitro.
Secondary ID [1] 312991 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Peritoneal Metastases 335172 0
Metastatic colorectal cancer 335173 0
Condition category
Condition code
Cancer 331664 331664 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivery of personalised Hyperthermic intraperitoneal chemotherapy (HIPEC) at the time of Cytoreductive Surgery, where the intraperitoenal drug choic is determined by a preclinical in-vitro drug assay performed on patient-derived tumour models in the laboratory. A tumour biopsy will be obtained at the time of routine staging laparoscopy and used to develop an in-vitro 3D tumour model in the laboratory to be tested against the three on-label Colorectal HIPEC drugs (Mitomycin-C, Oxaliplatin, Irinotecan).

The intervention (personalised HIPEC) will be performed at the time of routine cytoreductive surgery across all Australian Colorectal Peritoneal Malignancy Units. Personalised HIPEC will be delivered during the cytoreductive surgery after a complete cytoreduction has been performed, where no macroscopic peritoneal disease exists in the abdominal cavity. HIPEC will be delivered via either a closed technique (with closure of the abdomen and delivery via abdominal drains) or open coliseum technique. The intraperitoneal chemotherapy will be heated to 40-42 degrees Celsius. The drug choice for HIPEC delivery will be determined by the results of the preclinical drug assay and will be a choice of one of the following:
1) 60 minutes Mitomycin C 15mg/m2
2) 60 minutes Oxaliplatin 350mg/m2
3) 60 minutes Irinotecan 100mg/m2

Cytoreductive surgery will be performed with an open approach via a midline laparotomy, with an approximate average duration of 5 hours. All cytoreductions will be performed by surgeons with specialist experience in peritoneal malignancy and its management and only at specialist Peritoneal Malignancy units. Adherence to quality of cytoreduction and its completeness will be monitored using intra-operative photography to document complete cytoreduction as well as review of the procedural records.

The response of an individual organoid will be compared to the median response of the existing colorectal organoid library and a drug-sensitivity assay report will be generated to compare individual patient organoid response and determine individual sensitivity. Prior to release of the drug sensitivity report to the site investigator, results will be reviewed by a Personalised Medicine Tumour Board, consisting of a senior laboratory member, scientist, analyst and treating clinical team. The role of this board is to review assay results and govern their application into clinical practice.
Intervention code [1] 329524 0
Treatment: Other
Intervention code [2] 329590 0
Treatment: Drugs
Intervention code [3] 329591 0
Treatment: Surgery
Comparator / control treatment
This group consists of a historical cohort of patients with Colorectal Peritoneal Metastases who underwent CRS+HIPEC without a personalised approach at Peter MacCallum Cancer Centre and Royal Prince Alfred Hospital (between January 2014-December 2024), the two centres within Australia performing the highest volume of cytoreductions. Hence, the comparator will consist of peritoneal disease-free survival in an Australian cohort of patients between January 2014-December 2024, where a personalised HIPEC approach was not offered.
Control group
Historical

Outcomes
Primary outcome [1] 339391 0
Peritoneal disease free survival
Assessment method [1] 339391 0
Detection of recurrent peritoneal disease on surveillance radiological imaging (CT/MRI/FDG-PET) or on biopsy.
Timepoint [1] 339391 0
12 months (primary timepoint), 2-years and 3-years from the date of Cytoreductive Surgery and personalised Hyperthermic Intraperitoneal chemotherapy
Secondary outcome [1] 439742 0
Quality of life
Assessment method [1] 439742 0
Patient reported quality of life outcome measures will be reported as scores as per the validated Short Form 36 Version 2 (SF-36V2) questionnaire.
Timepoint [1] 439742 0
At the time of trial registration, 1 year and 2 years after Cytoreductive surgery and personalised HIPEC
Secondary outcome [2] 439743 0
Overall Survival
Assessment method [2] 439743 0
Overall survival is defined as the time from Cytoreductive Surgery and personalised Hyperthermic Intraperitoneal Chemotherapy to the date of death from any cause. Patients without an event by the study close-out date will be censored at the date they were last known to be alive.
Timepoint [2] 439743 0
1-year and 3-years post Cytoreductive surgery and personalised HIPEC
Secondary outcome [3] 439744 0
Colorectal-cancer specific survival
Assessment method [3] 439744 0
Colorectal-cancer specific survival is devined as the time from Cytoredutive surgery and Hyperthermic Intraperitoneal Chemotherapy to date of death from colorectal cancer or a complication of the colorectal cancer. Patients who die from causes unrelated to the disease, including other cancer are not counted in this measurement. patients who are alive and without an event by the study close-out date will be censored at the date they were last known to be alive.
Timepoint [3] 439744 0
1-year and 3-years post Cytoreductive surgery and personalised HIPEC
Secondary outcome [4] 439745 0
Adverse events
Assessment method [4] 439745 0
Adverse events will be reported according to CTCAE V5.0 and surgical complications accoridng to Clavien-Dindo Classification systems. Possible adverse events include: - Haematological toxicity (neutropaenia, leukopaenia, thrombocytopenia, anaemia) - Renal toxicity - Liver insufficiency - Venous thrombosis - Pleural effusion - Wound infection - Gastrointestinal perforation - Anastomotic leakage - Bowel obstruction - Fistula - Abscess
Timepoint [4] 439745 0
Date of discharge from admission pertaining to the index intervention (Cytoreductive surgery and personalised HIPEC)
Secondary outcome [5] 439746 0
Length of hospital stay
Assessment method [5] 439746 0
Length of hospital stay defined as from date of Cytoreductive surgery and personalised HIPEC till date of discharge from the same admission. Patient medical records will be used to determine the date of admission and date of discharge.
Timepoint [5] 439746 0
Date of discharge from admission pertaining to the index intervention (Cytoreductive surgery and personalised HIPEC)
Secondary outcome [6] 439747 0
Bowel-obstruction free survival
Assessment method [6] 439747 0
Bowel obstruction-free survival is defined as the time from Cytoreductive surgery and personalised HIPEC to the date of intestinal obstruction that is clinically or radiologically evident.
Timepoint [6] 439747 0
1-year and 3-years post Cytoreductive Surgery and personalised HIPEC
Secondary outcome [7] 440042 0
Health-related quality of life in colorectal cancer patients
Assessment method [7] 440042 0
Patient-reported health-related quality of life in colorectal cancer outcome measures will be reported as scores as per the validated EORTC QLQ-CR29 questionnaire.
Timepoint [7] 440042 0
At the time of trial registration, 1 year and 2 years after Cytoreductive surgery and personalised HIPEC
Secondary outcome [8] 440043 0
Surgical Complications
Assessment method [8] 440043 0
Surgical outcomes will be assessed according to the Clavien-Dindo Classification system.
Timepoint [8] 440043 0
Date of discharge from admission pertaining to the index intervention (Cytoreductive surgery and personalised HIPEC).

Eligibility
Key inclusion criteria
1. Patient has provided written informed consent using the PREDICTORG Patient Information and Consent Form (PICF)
2. Patient aged 18-85 years old at the time of signing consent.
3. Eastern Co-operative Oncology group (ECOG) performance status of 0-1
4. Patient deemed suitable for consideration of Cytoreductive surgery and HIPEC (i.e. radiologically has potentially resectable disease either upfront of after neoadjuvant chemotherapy)
NOTE: Any co-morbidities are allowed provided the patient is deemed operable.
5. Synchronous or metachronous peritoneal metastases
NOTE: Any previous radiotherapy or chemotherapy will be allowed, and no washout period is mandatory).
6. Histological confirmation of disease of colorectal adenocarcinoma origin.
NOTE: in the setting of patients waiting for a histological diagnosis at the time of laparoscopy and biopsy, a strong suspicion of Colorectal Peritoneal Metastases based on imaging or tumour marker status is required for recruitment.
7. Life expectancy of at least 12 weeks.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Extraperitoneal disease not amenable to curative treatment
2. Histology inconsistent with Colorectal Peritoneal Metastases (e.g. appendiceal cancer)
3. Previous Cytoreductive surgery and/or Hyperthemic Intraperitoneal Chemotherapy.
4. Patient already included in another first-line therapeutic trial for the disease studied.
5. Patients unable to undergo medical monitoring during the study due to geographical, social or psychological motives.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase IIb study comparing the primary outcome (peritoneal disease free survival) in the intervention group (Cytoreductive surgery + Personalised HIPEC) with a historical cohort of patients who did not receive personalised HIPEC (CRS + HIPEC).
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2028
Actual
Date of last data collection
Anticipated
1/01/2031
Actual
Sample size
Target
235
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 27102 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 27103 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 27104 0
St George Hospital - Kogarah
Recruitment hospital [4] 27105 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 27106 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 27107 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [7] 27108 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 43176 0
3000 - Melbourne
Recruitment postcode(s) [2] 43177 0
2050 - Camperdown
Recruitment postcode(s) [3] 43178 0
2217 - Kogarah
Recruitment postcode(s) [4] 43179 0
5011 - Woodville
Recruitment postcode(s) [5] 43180 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 43181 0
4101 - South Brisbane
Recruitment postcode(s) [7] 43182 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 317427 0
Charities/Societies/Foundations
Name [1] 317427 0
Tour de Cure
Country [1] 317427 0
Australia
Funding source category [2] 317428 0
Charities/Societies/Foundations
Name [2] 317428 0
Colorectal Surgical Society of Australia and New Zealand
Country [2] 317428 0
Australia
Funding source category [3] 317429 0
Charities/Societies/Foundations
Name [3] 317429 0
Royal Australasian College of Surgeons
Country [3] 317429 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Country
Australia
Secondary sponsor category [1] 319714 0
None
Name [1] 319714 0
Country [1] 319714 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316149 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 316149 0
Ethics committee country [1] 316149 0
Australia
Date submitted for ethics approval [1] 316149 0
30/10/2024
Approval date [1] 316149 0
Ethics approval number [1] 316149 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136942 0
Prof Alexander Heriot
Address 136942 0
Peter MacCallum Cancer Centre, 305 Grattan St Parkville, VIC 3000
Country 136942 0
Australia
Phone 136942 0
+61 406758865
Email 136942 0
alexander.heriot@petermac.org
Contact person for public queries
Name 136943 0
Alexander Heriot
Address 136943 0
Peter MacCallum Cancer Centre, 305 Grattan St Parkville, VIC 3000
Country 136943 0
Australia
Phone 136943 0
+61 406758865
Email 136943 0
alexander.heriot@petermac.org
Contact person for scientific queries
Name 136944 0
Anshini Jain
Address 136944 0
Peter MacCallum Cancer Centre, 305 Grattan St Parkville, VIC 3000
Country 136944 0
Australia
Phone 136944 0
+61 408332712
Email 136944 0
anshini.jain@petermac.org

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24197Study protocol  alexander.heriot@petermac.org
24198Ethical approval  alexander.heriot@petermac.org
24199Informed consent form  alexander.heriot@petermac.org
24200Statistical analysis plan  alexander.heriot@petermac.org



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.