Actively Recruiting
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2024-08-15
40
Participants Needed
6
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent for the trial
- Age 18 years or older at consent
- Newly diagnosed metastatic (stage IV) non-small cell lung cancer (NSCLC) not suitable for curative surgery or radiotherapy
- Histological or cytological confirmation of NSCLC
- EGFR/ALK/ROS1 wild-type status
- Primary tumor suitable for radiotherapy and does not need immediate palliative irradiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You will not qualify if you...
- Medically unfit for systemic therapy
- Positive for EGFR/ALK/ROS1 mutations
- Previous thoracic radiotherapy exceeding 36Gy in 12 fractions within 6 months before randomisation
- Diagnosed or treated with another malignancy within 3 years prior to randomisation, except treated basal cell carcinoma, squamous cell carcinoma of skin, early-stage cervical cancer, breast cancer, or prostate cancer without active disease
- History or current pneumonitis requiring corticosteroids over 10mg prednisolone daily
- Received systemic anti-cancer therapy within 4 weeks prior to randomisation
- Diagnosis of idiopathic pulmonary fibrosis
- Psychiatric or substance abuse disorders interfering with trial compliance
- Uncontrolled brain metastases not suitable for surgery or stereotactic radiotherapy
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Not Yet Recruiting
2
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not Yet Recruiting
3
Peter MacCallum Cancer Centre - Bendigo
Bendigo, Victoria, Australia, 3550
Actively Recruiting
4
Peter MacCallum Cancer Centre - Monash Cancer Centre
Bentleigh East, Victoria, Australia, 3165
Actively Recruiting
5
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
6
Sunshine Hospital Western Health
Sunshine, Victoria, Australia, 3000
Actively Recruiting
Research Team
S
Shankar Siva
CONTACT
C
CRDO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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