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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01014130




Registration number
NCT01014130
Ethics application status
Date submitted
8/10/2009
Date registered
16/11/2009
Date last updated
12/07/2017

Titles & IDs
Public title
Hypofractionated Radiotherapy (Stereotactic) Versus Conventional Radiotherapy for Inoperable Early Stage I Non-small Cell Lung Cancer (NSCLC)
Scientific 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)
Secondary ID [1] 0 0
TROG 09.02
Universal Trial Number (UTN)
Trial acronym
CHISEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Hypofractionated radiotherapy (HypoRT)
Treatment: Other - Conventionally Fractionated Radiotherapy (ConRT)

Active Comparator: Arm 2 - Conventionally Fractionated Radiotherapy (ConRT) - Standard of Care

Experimental: Arm 1 - Hypofractionated radiotherapy (HypoRT) - Investigational


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

Treatment: Other: Conventionally Fractionated Radiotherapy (ConRT)
Standard radiotherapy to a total dose of 60-66 Gy prescribed to an isodose covering the PTV. It will be delivered as 30-33 fractions over a period of six to six and a half weeks. If the use of chemotherapy is the institutional practice for this group of patients, concurrent carboplatin and paclitaxel will be given weekly (paclitaxel (45mg/m2/wk) and carboplatin (AUC=2/wk) for 6 weeks.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Local Failure
Timepoint [1] 0 0
Completion of the two year follow up period for all patients.
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Completion of the two year follow up period for all patients.
Secondary outcome [2] 0 0
Cancer Specific survival
Timepoint [2] 0 0
Completion of the two year follow up period for all patients.
Secondary outcome [3] 0 0
Treatment Related Toxicity
Timepoint [3] 0 0
Completion of the two year follow up period for all patients.
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
Completion of the two year follow up period for all patients.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Calvary Mater Hosipital - Newcastle
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Peter Maccallum Cancer Centre - Bendigo
Recruitment hospital [11] 0 0
Austin Hospital - Heidelburg
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Centre - Box Hill - Melbourne
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - Morrabbin - Melbourne
Recruitment hospital [15] 0 0
Alfred Hospital - Prahran
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2298 - Newcastle
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2069 - Sydney
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3952 - Bendigo
Recruitment postcode(s) [11] 0 0
3084 - Heidelburg
Recruitment postcode(s) [12] 0 0
3000 - Melbourne
Recruitment postcode(s) [13] 0 0
3128 - Melbourne
Recruitment postcode(s) [14] 0 0
3165 - Melbourne
Recruitment postcode(s) [15] 0 0
3181 - Prahran
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Palmerston North
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01014130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Ball, MBBSMDRANZCR
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01014130