Non Small Cell Lung Cancer Clinical Trial
— CHISELOfficial title:
A Randomised Phase III Trial of Highly Conformal Hypofractionated Image Guided ("Stereotactic") Radiotherapy (HypoRT) Versus Conventionally Fractionated Radiotherapy (ConRT) for Inoperable Early Stage I Non-small Cell Lung Cancer (CHISEL)
Verified date | July 2017 |
Source | Trans-Tasman Radiation Oncology Group (TROG) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Although surgery is the most effective treatment for early lung cancer, many patients
are not fit enough for an operation. The alternative treatment to surgery is standard
radiotherapy which is normally 'fractionated' that is, given as a number of small doses over
a period of weeks. Experience has shown that many small treatments are safer than using a few
large doses (hypofractionation) because there is less risk of damage to normal tissues.
Recent advances in technology have however resulted in greater accuracy and with it a
reduction in the amount of normal tissue affected by the radiation, so the risks of
hypo-fractionation damaging normal tissue are of less concern. Initial results obtained with
hypo-fractionated radiotherapy for early stage non-small cell lung cancer indicate that it
may be more effective in controlling the cancer. However, it has never been compared directly
with standard fractionation in a randomised trial, so this study aims to determine if
hypo-fractionation is more effective, results in longer life expectancy and if it is just as
safe as standard fractionation.
Status | Active, not recruiting |
Enrollment | 101 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion 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 (UICC TNM stage, 7th Ed, 2009), based on FDG PET/CT performed within 4-6 weeks prior to randomisation. T stage should be based on tumour size alone (i.e. no atelectasis). - An 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: - ANC = 1.5 x 109, - Platelets = 100 x 109/L, Hb = 100g/L, - Creatinine clearance = 40mls/min (patients with calculated creatinine clearance = 40mls/min and < 60mls/min must have this confirmed by nuclear medicine GFR scan), - Bilirubin < 1.5 x ULN, and - ALT or AST < 2x ULN. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Peter Maccallum Cancer Centre | Bendigo | Victoria |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Canberra Hospital | Canberra | Australian Capital Territory |
Australia | Austin Hospital | Heidelburg | Victoria |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
Australia | Peter MacCallum Cancer Centre - Box Hill | Melbourne | Victoria |
Australia | Peter MacCallum Cancer Centre - Morrabbin | Melbourne | Victoria |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Calvary Mater Hosipital | Newcastle | New South Wales |
Australia | Alfred Hospital | Prahran | Victoria |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Australia | Royal North Shore Hospital | Sydney | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
New Zealand | Canterbury District Health Board | Christchurch | |
New Zealand | Auckland Hospital | Epsom | Auckland |
New Zealand | Midcentral District Health Board | Roslyn | Palmerston North |
Lead Sponsor | Collaborator |
---|---|
Trans-Tasman Radiation Oncology Group (TROG) |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Local Failure | Completion of the two year follow up period for all patients. | ||
Secondary | Overall Survival | Completion of the two year follow up period for all patients. | ||
Secondary | Cancer Specific survival | Completion of the two year follow up period for all patients. | ||
Secondary | Treatment Related Toxicity | Completion of the two year follow up period for all patients. | ||
Secondary | Quality of Life | Completion of the two year follow up period for all patients. |
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