Actively Recruiting
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours
Led by Cancer Trials Ireland · Updated on 2025-05-02
68
Participants Needed
2
Research Sites
208 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
Researchers are evaluating the safety of a radiation therapy method called image-guided stereotactic ablative radiation therapy (IG-SABR) for patients with high-risk centrally located non-small cell lung cancer (NSCLC) tumors or a single pulmonary oligometastatic lesion. This phase II, non-randomized study focuses on patients whose disease cannot be treated with surgery and aims to assess side effects by monitoring the number and severity of treatment-related toxicities. Patients must meet specific criteria related to tumor and normal tissue radiation doses to be eligible. Treatment involves delivering radiation in 8 sessions (fractions), each with a dose of 7.5 Gy, using IG-SABR techniques that carefully target the tumor while respecting dose limits for surrounding normal tissues. The planning allows a minimum dose coverage between 75% and 95% of the planning target volume (PTV) and 75% to 99% of the gross tumor volume (GTV). Respiratory monitoring will be used during treatment, which employs photon beams of 6-10 MV energy. Optional translational sub-studies involve biomarker discovery and protein analysis and are available only at participating centers. Participants will be assessed weekly during treatment and at multiple time points after treatment, including 2, 4, 8 weeks, and then at 3, 6, 9, 12, 18, 24 months, followed by annual visits up to 5 years. These evaluations include toxicity monitoring and survival assessments. The main outcome measured is the rate of severe treatment-related toxicity within one year after treatment. The study aims to include 60 evaluable patients and will stop enrolling if excessive severe side effects occur. The study period includes up to 5 years of follow-up for long-term safety and effectiveness outcomes.
CONDITIONS
Brief Title
'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before study procedures
- 18 years of age or older
- Life expectancy greater than 6 months
- ECOG performance status between 0 and 2
- Diagnosis of primary non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell) or a single pulmonary oligometastatic lesion requiring local treatment
- Radiotherapy plan initially exceeding organ at risk dose constraints for full tumor coverage but meeting specific SOURCE Lung constraints with minimum dose coverage
- Inoperable tumor or patient refuses surgery
- Females of childbearing potential not pregnant or lactating and agreeing to contraception during treatment; males with partners of childbearing potential agreeing to contraception
- No psychological or social conditions likely to interfere with study compliance
You will not qualify if you...
- History of other malignancy within 5 years except treated basal or squamous cell skin carcinoma
- Tumor or lesion touching the esophagus
- Regional or distant metastases or metastatic pleural effusion in primary NSCLC
- Spinal canal involvement
- Conditions causing increased radiosensitivity
- Idiopathic pulmonary fibrosis or usual interstitial pneumonia
- Recent or planned chemotherapy/targeted therapy near radiation period
- Previous thoracic or mediastinal radiotherapy likely to interfere with study
- Tumor not clearly defined on planning CT scan
- Inability to undergo 4D-CT scan
- Uncontrolled illness interfering with treatment
- Other significant disorders or findings making participation unsafe or compliance unlikely
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 to 3 weeks
Participants receive image-guided stereotactic ablative radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy with specific dose constraints to target volumes and organs at risk.
8 treatment visits (in-person) with weekly toxicity assessments
Duration - Up to 5 years post treatment
Participants undergo toxicity assessments and monitoring for treatment-related adverse events and disease outcomes up to 5 years post treatment.
Weekly visits during treatment, then visits at 2, 4, and 8 weeks post-treatment; 3, 6, 9, 12, 18, 24 months post-treatment; and annually thereafter up to 5 years
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
P
Prof. John Armstrong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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