None listed
Conditions
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.
Interventions
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 year
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).
Sponsors
Bendigo Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed