Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05222087

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here