Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000653662p
Ethics application status
Not yet submitted
Date submitted
1/06/2023
Date registered
16/06/2023
Date last updated
16/06/2023
Date data sharing statement initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Oligoprogressive treatment for immunotherapy patients (OPTION)
Scientific title
A registry study to prospectively describe the proportion of advanced cancer patients being treated with immunotherapy who remain progression free at 6 months after local treatment of up to five sites of oligoprogressive disease
Secondary ID [1] 309809 0
nil known
Universal Trial Number (UTN)
Trial acronym
OPTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced solid organ tumours 330222 0
Condition category
Condition code
Cancer 327092 327092 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
To prospectively describe the proportion of advanced cancer patients being treated with immunotherapy who remain progression free at six months after local treatment of up to five sites of oligoprogressive disease. 33 participants will be recruited across 6 regional Victorian sites over a 2-year period. All participants will be followed until death or study completion, which will be when the last participant has had a minimum of 2 years follow-up. Overall, the study is expected to run for 4 years.
Participants will be observed for any adverse events associated with their local treatment, and will be followed through their standard appointments and re-staging to assess for disease progression.
Participants will have no additional appointments, investigations or testing, apart from those required as part of standard of care treatments. Participants will not have to complete any questionnaires or diaries. Therefore, apart from additional time required for consent and initial enrolment, participants will have no additional study-specific requirements. All data will come from the routine reviews and re-staging which will occur approximately every 3 months from enrolment to end of study (ie a minimum of 2 years and up to 4 years of follow-up).
Intervention code [1] 326238 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334954 0
Landmark progression-free survival, defined as from the time of completion of local therapy to progression. Progression will be inclusive of:
a) Further local therapy requirement
b) Change in systemic treatment for radiological or clinical progression
c) Active cessation of treatment to transition to best supportive care
d) Death
Tests and investigations will include standard re-staging imaging such as CT and MRI, and standard blood tests including tumour markers to assess for radiological and clinical response/progression.
Timepoint [1] 334954 0
The primary endpoint is to assess the proportion of patients who remain progression-free at 6 months from local therapy. Progression-free survival will be continue to be assessed at 12 weekly intervals, until study end at 4 years, as part of describing the change to treatment as per the secondary outcomes. Analysis performed at end of study.
Secondary outcome [1] 422531 0
Time to change in treatment or active decision for best supportive care. This is defined from the date of completion of local therapy to the date of change in treatment (includes further local therapy, change in systemic treatment, decision for best supportive care)
Timepoint [1] 422531 0
Data collected from review of medical records (for example, clinic notes, investigation reports, blood test results) every 12 weeks, until study end at 4 years. Analysis performed at end of study.
Secondary outcome [2] 422532 0
Overall survival, defined from date of completion of local therapy to the date of death from any cause.
Timepoint [2] 422532 0
Data collected from review of medical records (for example, clinic notes, investigation reports, blood test results) every 12 weeks, until study end at 4 years. Analysis performed at end of study.
Secondary outcome [3] 422533 0
To describe local treatment-related serious adverse events using the NCI Common Terminology for Adverse Events v5.0.
Timepoint [3] 422533 0
Data collected from review of medical records (for example, clinic notes, investigation reports, blood test results) every 12 weeks, until study end at 4 years. Analysis performed at end of study.

Eligibility
Key inclusion criteria
1. Patients with histologically proven advanced cancer receiving immunotherapy. Advanced cancer will include any unresectable locally advance or metastatic cancer, primary tumour agnostic. Accepted tumour types will include melanoma, lung cancer, renal cell carcinoma, urothelial cancer, head and neck cancers, and deficient MMR cancer of any primary.
2. On systemic immunotherapy, either alone or in combination the chemotherapy or another systemic treatment.
3. Must have evidence of extracranial metastatic disease with or without intracranial metastases.
4. Clinically or radiologically stable or responding disease to immunotherapy for a period of at least 12 weeks prior to study entry with ongoing clinical benefit as deemed by treating clinician.
5. Evidence of isolated progression in 1-5 lesions amenable to local treatment.
6. Planned local treatment to sites of oligoprogression which can include surgery and/or radiotherapy.
7. Baseline staging either via CT or PET/CT needs to be obtained within 4 weeks of commencement of local therapy. An MRI brain will be required for local therapy of oligoprogressive brain metastases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or lactation at the time of study entry
2. Primary brain tumours
3. Evidence of leptomeningeal disease
4. Evidence of malignant spinal cord compression
5. Contraindication to radiotherapy and/or surgery as local therapy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The proportion of patients who remain progression free at 6 months will be compared using the exact binomial probability test against a null hypothesis of 10%. It was considered on clinical grounds that a local treatment strategy would not be worthwhile in this patient population if 10% or less would remain progression free at 6 months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24834 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [2] 24835 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 40484 0
3350 - Ballarat Central
Recruitment postcode(s) [2] 40483 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 313993 0
Hospital
Name [1] 313993 0
Bendigo Health
Country [1] 313993 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
100 Barnard Street
Bendigo VIC 3550
Country
Australia
Secondary sponsor category [1] 315878 0
None
Name [1] 315878 0
Address [1] 315878 0
Country [1] 315878 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313129 0
Melbourne Health HREC
Ethics committee address [1] 313129 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 313129 0
Australia
Date submitted for ethics approval [1] 313129 0
28/06/2023
Approval date [1] 313129 0
Ethics approval number [1] 313129 0

Summary
Brief summary
This is a multi-site registry-based observational study across regional Victoria for people receiving immunotherapy treatment for an unresectable locally advanced or metastatic tumour.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced cancer that presents as a solid tumour and you have been receiving immunotherapy for at least 12 weeks, and the cancer has started growing again in a small number of areas.

Study details
Participants who choose to enrol in this study will be asked to consent to having their health information reviewed and collected in a de-identified manner by a member of the research team. Participants will not be asked to attend any additional clinic appointments as part of their involvement in this study nor will they receive specific treatments as part of the study. All treatment(s) received will be the standard treatment(s) otherwise recommended irrespective of participation on this study.

It is hoped this research will determine the proportion of patients who do not have cancer progression 6 months after they have completed local therapy, including surgery and/or radiotherapy, but continuing on immunotherapy. If immunotherapy is shown to have a beneficial impact on cancer progression for patients, the information gathered by this study may then be used to optimise treatment options for future cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127102 0
Dr Samuel Harris
Address 127102 0
Cancer Centre
Bendigo Health
100 Barnard Street
Bendigo VIC 3550
Country 127102 0
Australia
Phone 127102 0
+61 3 5454 8815
Fax 127102 0
Email 127102 0
sjharris@bendigohealth.org.au
Contact person for public queries
Name 127103 0
Ms Narelle McPhee
Address 127103 0
Cancer Centre
Bendigo Health
100 Barnard Street
Bendigo VIC 3550
Country 127103 0
Australia
Phone 127103 0
+61 472 682 360
Fax 127103 0
Email 127103 0
nmcphee@bendigohealth.org.au
Contact person for scientific queries
Name 127104 0
Dr Samuel Harris
Address 127104 0
Cancer Centre
Bendigo Health
100 Barnard Street
Bendigo VIC 3550
Country 127104 0
Australia
Phone 127104 0
+61 3 5454 8815
Fax 127104 0
Email 127104 0
sjharris@bendigohealth.org.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.