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Trial registered on ANZCTR


Registration number
ACTRN12619001186145
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
22/08/2019
Date last updated
15/11/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Stereotactic ablative radiotherapy for locally-advanced non-small cell lung cancer
Scientific title
Treatment of Locally Advanced non-small cell lung carcinoma with Stereotactic ablativE Radiotherapy
Secondary ID [1] 298185 0
None
Universal Trial Number (UTN)
U1111-1233-1716
Trial acronym
LASER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally-advanced non-small cell lung cancer 312769 0
Condition category
Condition code
Cancer 311265 311265 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 - dose escalation trial of stereotactic ablative radiotherapy (SABR).

Each dose arm delivers a tumour dose biologically equivalent to the conventional regime of 60 Gy in 30 fractions over 6 weeks.

Arm 1 - 50.4 Gy in 12 fractions over 2.5 weeks
Arm 2 - 46 Gy in 8 fractions over 2-3 weeks
Arm 3 - 42 Gy in 6 fractions over 2-3 weeks

Treatment will be prescribed by the treating radiation oncologist after a discussion at a multidisciplinary meeting. Treatment will be administered in the radiotherapy department at the hospital. During the SABR treatment you will be lying on a treatment couch whilst the radiation machine moves around you delivering the radiation. Prior to the treatment beginning the treatment staff will carry out imaging procedures to ensure the radiation is delivered accurately to your tumour. When the treatment machine is on you will not feel or see the radiation, you will only hear a buzzing noise. You will be in the treatment room for approximately 30 minutes for each treatment. Your treatment appointments will be scheduled Monday to Friday. In dose arms 2 and 3 you may have a day or two break between each treatment
Intervention code [1] 314417 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320011 0
Maximum tolerated dose (MTD) of SABR assessed using a bayesian data augmentation dose finding with the continual reassessment method (DA-CRM). MTD is determined by the occurrence of a dose limiting toxicity (DLT) (as defined by CTCAE criteria) up to 12 months after the first dose of radiotherapy.

A DLT is defined as:
- Any grade 4-5 acute toxicity occurring during or <90 days post completion of RT, or,
- Any grade 3-5 late toxicity occurring > 90 days post completion of radiotherapy and up to 12 months after the first dose of radiotherapy.
Timepoint [1] 320011 0
Toxicity will be assessed weekly throughout treatment and at 6 weeks, 3, 6 and 12 months following treatment completion via face-to face appointments with the treatment doctor. Patients will be instructed to notify the treatment doctor if any side effects occur between scheduled appointments. Side effects may occur in the surrounding thoracic organs such as lung, oesophagus, heart or blood vessels.
Secondary outcome [1] 370221 0
To assess the rate of acute, sub acute and chronic toxicity. Side effects may occur in the surrounding thoracic organs such as, but not limited to, lung, oesophagus, heart or blood vessels.
Timepoint [1] 370221 0
Toxicity will be assessed weekly throughout treatment and at 6 weeks, 3, 6, 12, 18, 24 months and yearly for up to 5 years following treatment completion via face-to face appointments with the treatment doctor. Patients will be instructed to notify the treatment doctor if any side effects occur between scheduled appointments.
Secondary outcome [2] 370222 0
Quality of life (QOL) assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the lung cancer-specific module QLQ-LC13.
Timepoint [2] 370222 0
6 weeks, 3, 6, 12, 18, 24 months and yearly for up to 5 years following treatment completion.
Secondary outcome [3] 370223 0
Tumour local and regional control as defined by the absence of progression at the treated sites as assessed on sequential CT imaging by a multidisciplinary group with or without PET confirmation.
Timepoint [3] 370223 0
3, 6, 12, 18, 24 months and yearly for up to 5 years post radiotherapy
Secondary outcome [4] 370224 0
Overall survival as determined by the time from first treatment to death. Notification of death will be via data linkage to medical records.
Timepoint [4] 370224 0
3, 6, 12, 18, 24 months and yearly for up to 5 years post radiotherapy

Eligibility
Key inclusion criteria
- Diagnosis of stage III or IV non-small cell lung carcinoma. Based on clinical or histologic grounds.
- Ineligible for standard of care concurrent chemoradiotherapy as determined by a multidisciplinary group.
- Estimated life expectancy >6 months. Scoring using a Victorian Lung Cancer Prognostic Index is suggested for guidance.
- Recommended a course of radiotherapy to the lung and mediastinal disease.
- Over 18 years of age and available for follow up.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous radiotherapy to the chest.
- History of another primary cancer within the last 2 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the radiotherapy or which may be potentially exacerbated by the treatment.
- Pregnant or breast feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Participants are recruited to consecutive/escalating dose levels, once recruitment has completed on prior level and safety has been shown.
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The Bayesian data augmentation continuous reassessment method (DA-CRM) will be used to analyse the accruing and final DLT data. The MTD is defined as the dose for which the median of the posterior probability distribution for the DLT rate is closest to the target rate (25%) and for which the safety criterion is met.

Tumour local and regional control and overall survival will be estimated by the Kaplan-Meier Method.

QOL will be analysed by repeated measures analysis using linear mixed models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13717 0
The Alfred - Prahran
Recruitment hospital [2] 13718 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 26442 0
3004 - Prahran
Recruitment postcode(s) [2] 26443 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 302722 0
Hospital
Name [1] 302722 0
Alfred Health
Address [1] 302722 0
55 Commercial Rd, Melbourne, VIC 3004
Country [1] 302722 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd, Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 302660 0
None
Name [1] 302660 0
Address [1] 302660 0
Country [1] 302660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303327 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303327 0
55 Commercial Rd, Melbourne, VIC 3004
Ethics committee country [1] 303327 0
Australia
Date submitted for ethics approval [1] 303327 0
08/05/2019
Approval date [1] 303327 0
25/06/2019
Ethics approval number [1] 303327 0
HREC/51429/Alfred-2019
Ethics committee name [2] 303682 0
Latrobe Regional Hospital Ethics Committee
Ethics committee address [2] 303682 0
Princes Highway
Traralgon West, VIC 3844
Ethics committee country [2] 303682 0
Australia
Date submitted for ethics approval [2] 303682 0
26/08/2019
Approval date [2] 303682 0
10/09/2019
Ethics approval number [2] 303682 0
2019-19

Summary
Brief summary
This study aims to evaluate whether stereotactic ablative radiotherapy (SABR) is a reasonable and safe treatment option for patients with non-small cell lung cancer (NSCLC) where their cancer is large and/or has also spread to the nearby lymph nodes.

Who is it for?
You may be eligible to join this study if you are aged 18 or older with a diagnosis of stage III or IV non-small cell lung carcinoma and ineligible for standard of care concurrent chemo-radiotherapy.

Study details
Participants in this study will undergo stereotactic ablative radiotherapy (SABR). SABR is a specialised form of radiotherapy whereby large doses of radiation are given in fewer treatments. Participants will attend between 6-12 SABR sessions across 2-3 weeks, and will then be followed up regularly post radiotherapy, in order to evaluate treatment safety, quality of life, tumour response and survival.

It is hoped this research will contribute to the field of oncology and improve the health outcomes of patients with lung cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93290 0
A/Prof Sasha Senthi
Address 93290 0
Alfred Health Radiation Oncology
55 Commercial Rd
Melbourne, VIC 3004
Country 93290 0
Australia
Phone 93290 0
+61 03 9076 2337
Fax 93290 0
+61 03 9076 2916
Email 93290 0
S.Senthi@alfred.org.au
Contact person for public queries
Name 93291 0
Ms Robin Smith
Address 93291 0
Alfred Health Radiation Oncology
55 Commercial Rd
Melbourne, VIC 3004
Country 93291 0
Australia
Phone 93291 0
+61 03 9076 2337
Fax 93291 0
+61 03 9076 2916
Email 93291 0
R.Smith@alfred.org.au
Contact person for scientific queries
Name 93292 0
A/Prof Sasha Senthi
Address 93292 0
Alfred Health Radiation Oncology
55 Commercial Rd
Melbourne, VIC 3004
Country 93292 0
Australia
Phone 93292 0
+61 03 9076 2337
Fax 93292 0
+61 03 9076 2916
Email 93292 0
S.Senthi@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results