Clinical trial · Interventional
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC/Oligometastatic Cancer (Single Lung Lesion) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation
- description
- Treatment will be delivered via image-guided (IG)-SABR in 8 fractions of 7.5Gy. OAR constraints must be respected but minimum dose coverage of 75% to 95% of the PTV will be allowed and minimum dose of 75% to 99% of the GTV will be allowed. The minimums are chosen to represent at least an equivalent BED to the RT standard fractionation of 55 Gy in 20 fractions based on actual treatment dose of 7.5Gy in 8 fractions. A total of 60 evaluable patients will be required for the study. The sample size was calculated using continuous monitoring for toxicity, up to one year post RT, using a Pocock-type boundary. Accrual will be halted if excessive numbers of ≥ Grade 3 TxR-AEs are seen. The regime will not be considered to be safe if \>25% of evaluable patients experience a ≥ Grade 3 treatment-related adverse event (TxR-AE) by the end of 1-year post-RT. This study will be considered adequately safe if ≤ 25% of evaluable patients experience ≥ Grade 3 TxR-AE by the end of 1 year post-RT.
- interventionNames
- Radiation: Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)
Primary outcomes (1)
- measure
- The rate of ≥ Grade 3 treatment-related toxicities occurring between start of treatment and one-year from the end of treatment using NCI CTCAE V5
- timeFrame
- From start of treatment to 1 year post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent obtained prior to any study-specific procedures 2. ≥ 18 years of age 3. Life expectancy \>6 months 4. ECOG (Eastern Cooperative Oncology Group) performance status 0-2 5. 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 6. 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 7. Inoperable (as per MDT) or patient refuses surgery, 8. 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 9. 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 Criteria: 1. 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 2. Tumour/oligometastatic lesion that is abutting the oesophagus 3. Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC 4. Spinal canal involvement 5. Patients with syndromes or conditions associated with increased radiosensitivity 6. Idiopathic pulmonary fibrosis / usual interstitial pneumonia 7. 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 8. 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 9. Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis) 10. Patients unable to undergo 4D-CT scan 11. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes 12. 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.
References
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