Status:
RECRUITING
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tumou...
Detailed Description
PRIME-Lung is an open-label randomised pilot study designed to assess the safety and feasibility of radiotherapy to the lung primary prior to commencement of standard of care (SOC) systemic therapy in...
Eligibility Criteria
Inclusion
- Have provided written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Newly diagnosed, metastatic (stage IV), non-small cell lung cancer (NSCLC), not amenable to curative surgery or curative radiotherapy
- Histological or cytologically documented NSCLC
- EGFR/ALK/ROS1 Wild-type
- Primary disease suitable for radiotherapy and not requiring immediate palliative irradiation
- ECOG 0-1
Exclusion
- Medically unfit for systemic therapy
- EGFR/ALK/ROS1 mutation positive
- Has had previous thoracic radiotherapy of \> 36Gy in 12 fractions (or equivalent) within the 6 months prior to randomisation.
- Has diagnosed and/or treated additional malignancy within 3 years prior to randomisation with the exception of: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated early-stage cervical cancer, breast cancer or prostate cancer with no evidence of active disease. Other exceptions may be considered following consultation with the principal investigator.
- Has a history of (non-infectious) pneumonitis or current pneumonitis that requires active corticosteroids with a dose equivalent of prednisolone\>10mg/d.
- Has had any systemic anti-cancer therapy within 4 weeks prior to randomisation
- A known diagnosis of idiopathic pulmonary fibrosis
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Uncontrolled brain metastases defined as not amenable to surgery or stereotactic radiotherapy
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05222087
Start Date
January 3 2022
End Date
April 1 2025
Last Update
August 15 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
2
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
3
Peter MacCallum Cancer Centre - Bendigo
Bendigo, Victoria, Australia, 3550
4
Peter MacCallum Cancer Centre - Monash Cancer Centre
Bentleigh East, Victoria, Australia, 3165