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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05222087
Registration number
NCT05222087
Ethics application status
Date submitted
6/01/2022
Date registered
3/02/2022
Titles & IDs
Public title
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
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Scientific title
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study
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Secondary ID [1]
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80476
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Universal Trial Number (UTN)
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Trial acronym
PRIME_LUNG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Radiotherapy
Treatment: Drugs - SoC systemic therapy
Active comparator: Arm 1: SoC systemic therapy -
Experimental: Arm 2: radiotherapy to lung primary, delivered before cycle three of SoC systemic therapy -
Treatment: Other: Radiotherapy
35Gy/5# Central 40Gy/5# Large Tumours \>5cm (non-central) 36Gy/12# or 40Gy/15# Ultracentral lesions 50Gy/5# Peripheral Tumours =5cm
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design.
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Assessment method [1]
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To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design. Technical feasibility will be assessed by the ability to deliver radiotherapy to the lung cancer primary whilst meeting dose constraints tumour prior to cycle 3 of SoC systemic therapy in metastatic NSCLC.
Radiotherapy to the primary in stage IV NSCLC will be considered worthwhile to be assessed in a large randomised study if radiotherapy is feasible in \>66% of patients randomised to the radiotherapy arm.
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Timepoint [1]
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18 months
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Secondary outcome [1]
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willingness to be randomised
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Assessment method [1]
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evaluate the proportion of patients who are willing to be randomised after being approached for the study.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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safety of Radiotherapy addition using NCI CTCAE
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Assessment method [2]
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The safety of the addition of radiotherapy by describing toxicity during the follow up period in each arm.
Safety will be measured as adverse events (AE) and serious adverse events (SAEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
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Timepoint [2]
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24 months
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Secondary outcome [3]
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PFS
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Assessment method [3]
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The study will also describe progression free survival within 6 months of follow-up. PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the Investigator following principles of RECIST 1.1, or death from any cause, whichever occurs first.
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Timepoint [3]
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24 months
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Gold Coast University Hospital - Southport
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Bendigo - Bendigo
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Monash Cancer Centre - Bentleigh East
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [6]
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Sunshine Hospital Western Health - Sunshine
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Recruitment postcode(s) [1]
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4215 - Southport
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3550 - Bendigo
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Recruitment postcode(s) [4]
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3165 - Bentleigh East
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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3000 - Sunshine
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/study/NCT05222087
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shankar Siva, A/Prof
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shankar Siva
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Address
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Country
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Phone
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+613 85595000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05222087