What is IG-SABR studying for centrally located non-small cell lung cancer?

This clinical trial is studying a special type of radiation therapy called image-guided stereotactic ablative radiation therapy (IG-SABR) to see if it is safe for treating high-risk lung tumors that cannot be removed by surgery. Researchers want to understand the side effects and risks of this treatment method. The study is sponsored by Cancer Trials Ireland and aims to improve care options for patients with this lung condition.

Who may be eligible for this NSCLC clinical trial?

Adults aged 18 or older with high-risk centrally located non-small cell lung cancer or a single lung lesion may be eligible. Participants must have a good performance status, a life expectancy over 6 months, and not have had recent chest radiotherapy or certain other medical conditions. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this NSCLC clinical trial?

Study-related care, including the study radiation therapy and all trial visits, is provided at no cost. Personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID04375904

SOURCE Lung Phase II Study of Image-Guided Stereotactic Ablative Radiation Therapy for High-Risk Central Non-Small Cell Lung Tumors and Single Lung Metastases

Led by Cancer Trials Ireland · Updated on 2025-05-02

Participants Needed

Research Sites

208 weeks

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Cancer Trials Ireland

Prof. John Armstrong

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