Hypofractionated image guided radiotherapy (stereotactic) versus conventional radiotherapy for inoperable early stage I non small cell lung cancer (NSCLC).

Phase 3

Active, not recruiting

• Conditions: Stage I non small cell lung cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12610000479000
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients may be included in the trial only if they meet all of the following criteria:
· Histologically or cytologically confirmed non-small cell lung cancer diagnosed within 6 weeks prior to randomisation. The following primary cancer types are eligible:
squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar
cell carcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise
specified.
· Aged 18 years or older
· Disease stage T1N0 or T2aN0 (International Union against Cancer (UICC Tumour, Nodes, Metastases (TNM) stage, 7th Ed, 2009), based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) performed within 4 weeks prior to randomisation. T stage should be based on tumour size alone (i.e. no atelectasis).
· An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
· The tumour has a peripheral location, defined as at least 1 cm beyond the
mediastinum and 2 cm beyond the bifurcation of the lobar bronchi.
Tumour is assessed as inoperable either i) because of unfitness for surgery as
determined by the lung multidisciplinary team including thoracic surgeons and
respiratory physicians or ii) because the patient refuses surgery.
· Female patients of childbearing potential and male patients must agree to use
adequate contraception throughout the treatment phase of the study.
· If female and of childbearing potential, a negative pregnancy test was performed within 7 days prior to randomisation.
· Patient is expected to survive and be available for follow up for two years.
· Patient has provided written informed consent for participation in this trial prior to any protocol-specified procedures.
· Patient undergoing chemoradiation has satisfactory haematological and biochemical
parameters as described below:
Absolute Neutrophil count (ANC) greater than or equal to 1.5 x 109, Platelets greater than or equal to 100 x 109/L, Hemoglobin (Hb) greater than or equal to 100g/L, creatinine clearance greater than or equal to
40mls/min (patients with calculated creatinine clearance greater than or equal to 40mls/min and < 60mls/min must have this confirmed by nuclear medicine Glomerular Filtartion Rate (GFR) scan), bilirubin <1.5 x Upper Limit of Normal (ULN) and Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST)< 2x

Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for admission to the trial:
· Centrally located tumours (< 1.0 cm from mediastinum or < 2.0 cm from bifurcation of
lobar bronchus).
· Tumours within 1.0 cm of the chest wall.
· Prior chemotherapy.
· Previous radiotherapy to the area to be treated.
· Women who are pregnant or lactating.
· Patient with multiple synchronous primary tumours requiring radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Local Failure. Measured from date of randomisation to time of local failure. Local failure will be measured via clinical assessment (physical examination and imaging where indicated) and measurement of local disease using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria[At baseline, weekly during radiotherapy treatment, 3 monthly (post radiotherapy) for 2 years, then 6 monthly until 2 years following the end of treatment.]