High dose palliative radiotherapy in patients with metastatic malignancy who cannot or will not have standard of care such as chemotherapy or other drug treatment
Feasibility of delivering High Dose Palliative Radiotherapy in patients with Metastatic malignancy
Sunshine Coast University Hospital
90 participants
Dec 9, 2025
Interventional
Conditions
Summary
This study is trying to determine whether giving palliative radiation therapy to all known sites of cancer in the body for patients with metastatic cancer can slow down the growth of disease, reduce the rate of new sites developing, improve overall survival and/or improve quality of life. Who is it for? You may be eligible for this study if you are aged 18 years or older and have been diagnosed with a metastatic cancer, including oesophageal, pancreatic, head and neck cancer, cutaneous squamous cell carcinoma, colorectal cancer, bladder cancer, triple-negative breast cancer, non-small cell lung cancer and skin cancer and you are not currently undertaking any oral and/or intravenous therapies for your cancer. Study details Participants who choose to enrol in this study will undergo at least one radiotherapy treatment course which will involve attending 5 radiotherapy sessions scheduled 2-3x per week over 2 weeks. Radiotherapy will be delivered to specific sites of the body depending upon each individual's metastases. At the end of the treatment course, participants will be asked to undergo different types of CT scans and/or a PET scan to review the effect of the radiotherapy on the metastases. If required, participants may undergo an additional treatment course of 5 sessions after a four week break. This treatment process will then be repeated until all known cancer sites have been treated. At 12 months, 2 and 3 years after enrolling into the study, participants will also be asked to attend different CT scans and/or PET scan to review their cancer status and will also be asked to complete a questionnaire regarding their quality of life. It is hoped this research will determine whether the use of radiotherapy alone is effective in the treatment of cancer metastases in patients who are not able to receive oral and/or intravenous therapies.
Eligibility
Inclusion Criteria6
- Aged 18 years or more.
- Able to give informed consent.
- Metastatic cancer (TxNxM>0 or International Federation of Gynecology and Obstetrics (FIGO) IV) based on staging CT-CAP +/- CT-B +/- CT-N or whole-body PET-CT +/- CT-B.
- Burden of disease able to be encompassed within standard organ at risk (OAR) constraints.
- Eastern Cooperative Oncology Group (ECOG) status 0-2.
- Patient deemed unsuitable for systemic therapy by treating Medical Oncologist OR patient declined systemic therapy offered by Medical Oncologist.
Exclusion Criteria10
- Patients currently receiving systemic therapy (cytotoxic chemotherapy, immunotherapy, biologic, hormone, or molecularly targeted therapy).
- Patients with metastatic malignancy with disease progression whilst receiving systemic therapy that do not have a further line of systemic therapy available to them.
- Life expectancy <3 months.
- Breast (except for triple negative disease), prostate, haematological or primary central nervous system (CNS) malignancies.
- Intracranial metastases not suitable for localised treatment (i.e., resection or stereotactic radiotherapy).
- Previous radiotherapy precluding treatment of current metastatic sites.
- Pregnancy.
- Intercurrent illness that will interfere with radiotherapy delivery.
- Treatment toxicity expected to reduce QoL significantly e.g., treatment to bilateral parotids.
- Prior diagnosis of connective tissue disorder.
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Interventions
Patients will receive standard doses of high-dose palliative radiotherapy to sites of metastatic disease until all known sites of disease have been treated. Each treatment course will consist of 5 treatments delivered 2-3x per week over the course of 2 weeks. Up to six sites of disease will be treated concurrently. If required, further sites will be treated after a four week break with this process repeated until all known disease has been treated. Radiotherapy dose and fractionation will be between 20Gy-30Gy in 5 fractions depending on location and size of tumour. There is no maximum number of treatment courses set that can be delivered to patients. There is a minimum of 1 treatment course. Patients will be asked to undergo one or multiple different types of CT scans and/or a PET scan to assess the impact of radiotherapy on the metastases. The treating clinician will then determine if further treatment is required. Patients will have radiotherapy planning performed approximately 2 weeks prior to radiotherapy treatment. Treatment will be delivered in line with standard practice at Sunshine Coast University Hospital and will be overseen by a Senior Radiation Oncologist. Adherence will be monitored by review of electronic medical records.
Locations(1)
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ACTRN12625001151426