ActivePhase 3ACTRN12610000479000

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

Trans Tasman Radiation Oncology Group (TROG) 09.02 - A randomised phase III trial comparing time to local failure between highly conformal hypofractionated image guided ("stereotactic") radiotherapy (HypoRT) versus conventionally fractionated radiotherapy for inoperable early stage I non small cell lung cancer

Sponsor

Trans Tasman Radiation Oncology Group (TROG)

Enrollment

100 participants

Start Date

Dec 31, 2009

Study Type

Interventional

Conditions

Stage I non small cell lung cancer

Summary

The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Who is it for? You may be eligible to join this study if you aged 18 years or above and have a confirmed diagnosis of non-small cell lung cancer within 6 weeks of study enrolment. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard of care treatment, which consists of chemotherapy and radiotherapy given in a number of small doses over a period of about 6 weeks. Participants in the other group will instead receive hypofractionated radiotherapy (HypoRT) in three large doses over a period of 2 weeks. All participants will be regularly monitored for up to 2 years in order to evaluate treatment response, survival, toxicity and quality of life. This will help us to determine whether hypofractionated radiotherapy is more effective, results in longer life expectancy and if it is just as safe as standard fractionated radiotherapy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria22

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
mls/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 ULN

Exclusion Criteria8

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.

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Interventions

Arm 1: Investigational. Treatment: Other - Hypofractionated radiotherapy (HypoRT). Highly conformal hypofractionated radiotherapy to a total dose of 54Gy in 3 fractions, 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed.