A Phase II Study of Stereotactic Ablative Body Radiotherapy (SABR) for Stage I Non-Small Cell Lung Cancer (NSCLC)

Assessing the feasibility of Stereotactic Ablative Body Radiotherapy (SABR) for stage I Non-Small Cell Lung Cancer (NSCLC): A single arm prospective phase II non-randomized multicentre study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000478617

Acronym

SABR Lung

Enrollment

134

Registered

2014-05-08

Start date

2013-07-29

Completion date

2019-07-29

Last updated

2022-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the efficacy of stereotactic ablative radiation therapy for treatment of Stage I non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Stage I non-small cell lung cancer. You must be able to lie flat and comply with the requirements of simulation and treatment. Participants in this study will be treated with stereotactic ablative radiation therapy with one of three dose and fractionation regimens. For peripheral lesions treatment dose will be 48 Gy in 4 fractions or 54 Gy in 3 fractions, depending on tumour size. For central lesions 50 Gy will be administered in 5 fractions. Overall treatment duration will vary from 11 – 14 days. Local control at 24 months is the primary endpoint of the study and is assessed by CT scans. Patients will be followed up until 5 years post treatment. A total of 100 patients will be recruited in this study.

Interventions

Stereotactic ablative body radiotherapy Patients will be assigned to 1 of 3 treatment arms, dependent on site of the lesion. 1. Peripheral lesions: - Tumour GTV less than 1.5 cm from ribs: 48 Gy in 4 fractions (12Gy/#) - Tumour GTV greater than or equal to1.5 cm from ribs: 54 Gy in 3 fractions (18Gy/#) 2. Central lesions: - 50 Gy in 5 fractions (10Gy/#) Two to three treatments are to be delivered per week. There must be a minimum break of 1 day and a maximum break of 4 days between fractions. T

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of non-small cell lung cancer -Pathological diagnosis is desirable where this can be achieved. -Diagnosis based on imaging: requires evidence that lesion(s) are increasing in size on 2 consecutive CT scans and /or increased uptake on PET. Stage T1-T2, N0M0 (AJCC Staging, 6th ed.) with tumour size less than or equal to 5 cm, based upon: -History and physical examination 4 weeks prior to registration. -CT chest, abdomen and pelvis and/or -FDG PET-CT scan ECOG performance status of less than or equal to 2 Patients must be able to lie flat and comply with the requirements of simulation and treatment. Patients with previous thoracic radiotherapy are permitted, provided V20 less than 15% on previous treatment an no overlap with intended current radiotherapy field Patients with previous history of malignancy may be included provided the previous malignancy is in remission and after a MDT discussion the current lung lesion is thought to be more likely of lung primary rather than metastatic disease

Exclusion criteria

Pregnant women Inability to lie flat and tolerate immobilization for duration of planning and treatment

Outcome results