Trial from ANZCTR


Trial ID ACTRN12610000479000
Trial Status: Registered
Date Submitted: 3/12/2009
Date Registered: 10/06/2010
Retrospectively registered

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Public title Hypofractionated image guided radiotherapy ("stereotactic") versus conventional radiotherapy for inoperable early stage I non small cell lung cancer (NSCLC).
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 1169 0
Clinical Trials.gov Registry ID NCT01014130
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UTN
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Trial acronym CHISEL
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Health condition(s) or problem(s) studied:
Stage I non small cell lung cancer 252337 0
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Condition category: Condition code:
Cancer Lung - Non small cell
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Descriptions of intervention(s) / exposure 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.
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Intervention Code:
Treatment: Other 255647 0
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Intervention Code:
Treatment: drugs 255648 0
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Comparator / control treatment Arm 2: Standard of Care. Treatment: other - Conventionally fractionated radiotherapy (ConRT). Standard radiotherapy to a total dose of 60-66Gy delivered in daily 2Gy in 30-33 fractions over 6-6.5 weeks.

Treatment: drugs - Carboplatin. If chemotherapy is the institutional practice for this group of patients, concurrent carboplatin (Area Under the Curve (AUC)=2/wk) will be given weekly with paclitaxel for 6 weeks.

Treatment: drugs - Paclitaxel. If chemotherapy is the institutional practice for this group of patients, concurrent paclitaxel (45mg/m2/wk) will be given intravenously, weekly with carboplatin for 6 weeks..
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Control group Active
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Primary Outcome: 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 253408 0
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Timepoint: At baseline, weekly during radiotherapy treatment, 3 monthly (post radiotherapy) for 2 years, then 6 monthly until 2 years following the end of treatment. 253408 0
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Secondary Outcome: Overall Survival. Measured from date of randomisation to death from any cause. Clinical assesments and ongoing follow-up. 262511 0
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Timepoint: Completion of two year follow-up period for all patients. Patients will be assesed within two weeks of starting radiotherapy, weekly during radiotherapy (or in the case of the experimental arm, on each day of treatment), then at 1 month post radiotherapy, then every 3 months for 2 years and then 6 monthly until two years following the end of treatment of the last patient to be accrued. 262511 0
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Secondary Outcome: Cancer Specific Survival. Measured from date of randomisation to cancer related death. Any clinical assessment, imaging or other clinically significant assessment used to diagnose cancer related death. 262512 0
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Timepoint: Completion of two year follow-up period for all patients. Patients will be assesed within two weeks of starting radiotherapy, weekly during radiotherapy (or in the case of the experimental arm, on each day of treatment), then at 1 month post radiotherapy, then every 3 months for 2 years and then 6 monthly until two years following the end of treatment of the last patient to be accrued. 262512 0
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Secondary Outcome: Toxicity. Measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTC AE) v 4.0. 262513 0
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Timepoint: Completion of two year follow-up period for all patients. Patients will be assesed within two weeks of starting radiotherapy, weekly during radiotherapy (or in the case of the experimental arm, on each day of treatment), then at 1 month post radiotherapy, then every 3 months for 2 years and then 6 monthly until two years following the end of treatment of the last patient to be accrued. 262513 0
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Secondary Outcome: Quality of Life. Measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Cancer 30 (EORTC QLQ-C30) and Lung Cancer (LC13). 262514 0
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Timepoint: At baseline, last day of radiotherapy, then 3 monthly (post radiotherapy) for 2 years, then 6 monthly until 2 years following the end of treatment. 262514 0
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Key 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 ULN
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key 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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Prior to patient enrolment, the investigator should ensure that all of the following
requirements are met:
· The patient meets all inclusion criteria and none of the exclusion criteria should apply.
· The patient has signed and dated the consent form.
· All pre-randomisation baseline assessments and investigations have been performed.
· The eligibility checklist has been completed, signed and dated.
The following documents should be faxed to the TROG Trial Centre:
· Eligibility checklist
· De-identified consent form
· Histological/cytological report confirming NSCLC
The Trial Coordinator will verify the completeness of the eligibility checklist upon receipt of the document and follow up with the participating centre in the event of a discrepancy.
Participants will be randomised in the ratio of 1:1 using the minimisation technique.
This is not a blinded study, treatment allocation is known.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Participants will be stratified by T stage (T1 or T2a) and whether medically operable or inoperable. Randomisation will be by the minimisation technique.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 31/12/2009
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Date of first participant enrolment 31/12/2009
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Anticipated date last participant recruited/enrolled 31/12/2016
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Actual date last participant recruited/enrolled
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Target sample size 100
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Hospital: The Canberra Hospital - Garran 1685 0
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Hospital: Liverpool Hospital - Liverpool 1686 0
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Hospital: Prince of Wales Hospital - Randwick 1687 0
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Hospital: Royal North Shore Hospital - St Leonards 1688 0
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Hospital: Royal Prince Alfred Hospital - Camperdown 1689 0
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Hospital: Princess Alexandra Hospital - Woolloongabba 1690 0
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Hospital: Royal Brisbane & Womens Hospital - Herston 1691 0
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Hospital: The Townsville Hospital - Douglas 1692 0
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Hospital: The Royal Adelaide Hospital - Adelaide 1693 0
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Hospital: The Alfred - Prahran 1694 0
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Hospital: Peter MacCallum Cancer Institute - East Melbourne 1695 0
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Hospital: Sir Charles Gairdner Hospital - Nedlands 1696 0
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Hospital: Peter MacCallum Cancer Centre, Moorabbin 1697 0
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Recruitment outside Australia

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Funding Source: Government body 256126 0
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Name: Cancer Australia 256126 0
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Address: PO BOX 1201
Dickson ACT 2602
256126 0
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Country: Australia 256126 0
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Primary Sponsor Other Collaborative groups
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Name: Trans Tasman Radiation Oncology Group (TROG)
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Address: Central Operations Office
Calvary Mater Newcastle
Locked Bag 7 Hunter Region Mail Centre (HRMC)
NSW 2310
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Country: Australia
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Secondary Sponsor: Individual 251468 0
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Name: Professor David Ball 251468 0
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Address: Peter MacCallum Cancer Centre
1 St Andrews Place
East Melbourne, Victoria, 3002
251468 0
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Country: Australia 251468 0
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Other Collaborator: Other Collaborative groups 277701 0
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Name: Australasian Lung cancer Trials Group (ALTG) 277701 0
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Address: 44 Brookes Street
Bowen Hills, QLD 4006
Australia
277701 0
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Country: Australia 277701 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Peter MacCallum Cancer Centre Ethics Committee 258217 0
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Address: Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Locked Bag 1, A Beckett St
East Melbourne
Victoria 8006
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Country: Australia 258217 0
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Approval Date: 258217 0
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Submitted Date: 258217 0
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HREC: 09/42 258217 0
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Brief 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. 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 hypofractionation damaging normal tissue are of less concern. Initial results obtained with hypofractionated 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 hypofractionation is more effective, results in longer life expectancy and if it is just as safe as standard fractionation.
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Trial website www.trog.com.au
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Dr
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Name: David Ball
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Address: Peter MacCallum Cancer Centre Locked Bag 1, A’Beckett Street East Melbourne VIC 8006
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Country: Australia
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Tel: +61 3 9656 1648
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Fax:
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Email: david.ball@petermac.org
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Contact person for public queries
Title: Ms
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Name: Marijana Vanevski
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Address: BaCT Peter MacCallum Cancer Centre 1 St Andrews Place East Melbourne, Victoria, 3002
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Country: Australia
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Tel: +61 3 9656 1266
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Fax: +61 3 9656 1420
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Email: Marijana.Vanevski@petermac.org
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Contact person for scientific queries
Title: Ms
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Name: Marijana Vanevski
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Address: BaCT Peter MacCallum Cancer Centre 1 St Andrews Place East Melbourne, Victoria, 3002
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Country: Australia
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Tel: +61 3 9656 1266
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Fax: +61 3 9656 1420
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Email: Marijana.Vanevski@petermac.org
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Contact person responsible for updating information
Title:
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Name: Trans Tasman Radiation Oncology Group (TROG)
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Address: Central Operations Office Calvary Mater Newcastle Locked Bag 7 HRMC NSW 2310
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Country: Australia
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Tel: +61 2 4014 3911
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Fax: +61 2 4014 3902
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Email: administrator@trog.com.au
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Addition Cancer fields
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