Oligoprogressive treatment for immunotherapy patients (OPTION)

Not Applicable

• Conditions: Advanced solid organ tumours; Cancer - Other cancer types

• Registration Number: ACTRN12623000653662
• Lead Sponsor: Bendigo Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-16
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: Observational
• Study Design: Not specified