Status:
RECRUITING
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
Lead Sponsor:
Cancer Trials Ireland
Collaborating Sponsors:
Technological University Dublin
University College Dublin
Conditions:
NSCLC/Oligometastatic Cancer (Single Lung Lesion)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radi...
Detailed Description
This study is a phase II non-randomised, multi-centre, single arm trial of image-guided (IG)-SABR for patients with high-risk centrally located T1-T4 lung tumours (NSCLC) or a single pulmonary oligome...
Eligibility Criteria
Inclusion
- Written informed consent obtained prior to any study-specific procedures
- ≥ 18 years of age
- Life expectancy \>6 months
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Histological diagnosis (biopsy or cytology) or radiological diagnosis (PET-positive FDG-avid tumour which has only one lesion to be treated for the purpose of the study / CT-based diagnosis for non FDG-avid tumour) which requires local ablative therapy per Multi-Disciplinary Team (MDT) recommendations) of either:
- (i) Primary NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell) OR (ii) Single pulmonary oligometastatic lesion to be treated for the purpose of the study
- Patients with central lung tumours/lesions whose radiotherapy plan meets the following criteria:
- (i) OAR eligibility constraints are initially exceeded when full PTV coverage is met; (ii) subsequently meets the CTRIAL-IE 18-33 SOURCE OAR Lung constraints and meets CTRIAL-IE 18-33 SOURCE Lung minimum constraints
- Inoperable (as per MDT) or patient refuses surgery,
- Females of childbearing potential must not be pregnant or lactating, must be prepared to take adequate contraception methods during treatment. Males whose female partners are of childbearing potential must be prepared to take adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control
- Absence of psychological, familial, sociological or geographical condition, or psychiatric illness/social situation potentially hampering compliance with the study protocol and follow-up schedule
Exclusion
- Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin)) which is likely to interfere with treatment or assessment of outcomes
- Tumour/oligometastatic lesion that is abutting the oesophagus
- Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC
- Spinal canal involvement
- Patients with syndromes or conditions associated with increased radiosensitivity
- Idiopathic pulmonary fibrosis / usual interstitial pneumonia
- Chemotherapy and/or other targeted therapy administered within 3 months prior to study radiotherapy or planned for \<6 weeks following radiotherapy for patients with primary NSCLC, or within 1 week prior to study radiotherapy or planned within 1 week following radiotherapy for patients with an oligometastatic lesion
- Any previous radiotherapy to the thorax or mediastinum (excluding previous breast or chest wall radiotherapy) which is likely to interfere with treatment or assessment of outcomes
- Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis)
- Patients unable to undergo 4D-CT scan
- Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2032
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04375904
Start Date
December 22 2020
End Date
February 1 2032
Last Update
May 2 2025
Active Locations (2)
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1
Beacon Hospital
Dublin, Ireland
2
St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital
Dublin, Ireland