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

Phase 2

Active, not recruiting

• Conditions: on-small cell lung cancer, stage T1-T2, N0M0 (AJCC staging, 6th ed.); Non-small cell lung cancer, stage T1-T2, N0M0 (AJCC staging, 6th ed.); Cancer - Lung - Non small cell

• Registration Number: ACTRN12614000478617
• Lead Sponsor: Dr Eric Hau

Brief Summary

Collaborative Implementation of Stereotactic Ablative Body Radiotherapy - A model for the safe implementation of complex radiotherapy techniques in Australia

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-08
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal control <br>The primary lung tumour (target lesion) is measured by CT scans and evaluated using the Revised Response Evaluation Criteria in Solid Tumours (RECIST) Guideline version1.1. Local control consists of Complete Response or Partial Response or Stable Disease and will be correspond to the absence of Local Failure.[baseline, 4 weeks post-treatment, then 3 montly until 24 months ]