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PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
Sponsor: Peter MacCallum Cancer Centre, Australia
Summary
Outcome for patients diagnosed with advanced lung cancer remains poor; alternative treatment options are urgently needed. Studies in other metastatic cancers indicate radiotherapy to the primary tumour can improve outcomes. The investigators postulate this will also be observed in lung cancer patients. The aim of this pilot study is to assess the safety and feasibility of stereotactic ablative radiotherapy (SABR) to the lung primary prior to standard of care (SoC) systemic therapy in advanced non-small cell lung cancer (NSCLC). Forty patients with advanced (Stage IV) NSCLC will be recruited across the five Peter Mac campuses. Patients will be randomised to receive SoC systemic therapy with or without radiotherapy to the lung primary. Radiotherapy will be delivered before cycle 3 of SoC systemic therapy. Biospecimens will be collected for future translational research. The primary outcome of the study (feasibility of the protocol) will be assessed by the ability to deliver radiotherapy to the lung cancer primary, whilst meeting dose constraints. The study will also 1) evaluate proportion of patients who are willing to be randomised; 2) describe toxicity during the follow up period in each arm; 3) describe progression free survival.
Official title: PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-01-03
Completion Date
2025-04
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
Radiotherapy
35Gy/5# Central 40Gy/5# Large Tumours \>5cm (non-central) 36Gy/12# or 40Gy/15# Ultracentral lesions 50Gy/5# Peripheral Tumours ≤5cm
SoC systemic therapy
Permitted SoC chemoimmunotherapy for squamous patients will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Paclitaxel. Carbo/Paclitaxel/Pembro intravenous infusions are given every 3 weeks for cycle 1-4, followed by ongoing maintainence with Pembrolizumab from Cycle 5. For non-squamous patients, SoC chemoimmunotherapy will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Permetrexed. Carboplatin/Pemetrexed/Pembrolizumab infusions are given every 3 weeks for four cycles followed by maintenance with Pemetrexed/Pembrolizumab from Cycle 5.
Locations (6)
Gold Coast University Hospital
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre - Bendigo
Bendigo, Victoria, Australia
Peter MacCallum Cancer Centre - Monash Cancer Centre
Bentleigh East, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sunshine Hospital Western Health
Sunshine, Victoria, Australia