Actively Recruiting
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
Led by Cancer Trials Ireland · Updated on 2025-05-02
68
Participants Needed
2
Research Sites
579 weeks
Total Duration
On this page
Sponsors
C
Cancer Trials Ireland
Lead Sponsor
T
Technological University Dublin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.
CONDITIONS
Official Title
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be 18 years of age or older
- Have a life expectancy greater than 6 months
- Have an ECOG performance status of 0 to 2
- Have a confirmed diagnosis (histological or radiological) of primary NSCLC or a single pulmonary oligometastatic lesion requiring local ablative therapy
- Have a radiotherapy plan that initially exceeds organ at risk constraints with full PTV coverage but meets SOURCE Lung dose constraints with potentially reduced dose coverage
- Be medically inoperable or have refused surgery
- For females of childbearing potential, not be pregnant or lactating and agree to use effective contraception during treatment
- Male participants with partners of childbearing potential must agree to use effective contraception during treatment
- Have no psychological, familial, sociological, or geographical conditions or psychiatric illness/social situations that may interfere with compliance and follow-up
You will not qualify if you...
- Have a known co-existing or prior malignancy within the last 5 years, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
- Have a tumor or lesion abutting the esophagus
- Have evidence of regional lymph node or distant metastases or metastatic pleural effusion (for primary NSCLC patients)
- Have spinal canal involvement
- Have syndromes or conditions associated with increased radiosensitivity
- Have idiopathic pulmonary fibrosis or usual interstitial pneumonia
- Have received chemotherapy or targeted therapy within 3 months before radiotherapy or planned within 6 weeks after radiotherapy (for primary NSCLC), or within 1 week before or after radiotherapy (for oligometastatic lesion patients)
- Have had prior radiotherapy to the thorax or mediastinum (excluding breast or chest wall radiotherapy) likely to interfere with treatment
- Have tumors not clearly definable on planning CT scan (e.g., due to consolidation or atelectasis)
- Be unable to undergo 4D-CT scanning
- Have uncontrolled intercurrent illness likely to interfere with treatment or outcome assessment
- Have any other significant clinical disorder or laboratory abnormality making participation undesirable or inability to comply with protocol
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beacon Hospital
Dublin, Ireland
Actively Recruiting
2
St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital
Dublin, Ireland
Actively Recruiting
Research Team
C
Cancer Trials Ireland
CONTACT
P
Prof. John Armstrong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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