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Trial registered on ANZCTR


Registration number
ACTRN12620000087954
Ethics application status
Approved
Date submitted
12/12/2019
Date registered
3/02/2020
Date last updated
29/09/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
LUMOS: Low & Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS – Pilot Study
Scientific title
To perform a pilot study on patients with progressive G2/3 glioma after treatment with radiotherapy and chemotherapy, who consent to resection of tissue for molecular typing or analysis of tissue resected at surgery within six months prior to enrolment, with a view of treatment with matched targeted agents where available, or else treatment with standard of care therapies.
Secondary ID [1] 300043 0
COGNO 19/05
Secondary ID [2] 300044 0
CTC 0267
Universal Trial Number (UTN)
Trial acronym
LUMOS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Grade 2 glioma (low grade) 315559 0
Grade 3 glioma (intermediate grade) 315560 0
Condition category
Condition code
Cancer 313846 313846 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will undergo molecular testing using a standardised molecular panel (Illumina TruSight 170 panel) to identify mutations for treatment with matched targeted agents where available or treatment with standard of care therapies. Treatments provided to the patient will be at the discretion of the treating physician and monitored for their efficacy. Patients will be reviewed and assessed 8 weekly until disease progression or 2 years after registration to the study. Blood tests and imaging assessments will be collected during the study.
Intervention code [1] 316320 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322242 0
Number of patients enrolled
Timepoint [1] 322242 0
This is defined as the absolute number of patients successfully enrolled for molecular phenotyping over the lifetime of the study
Primary outcome [2] 322243 0
Number of patients that successfully complete molecular profiling
Timepoint [2] 322243 0
This is the absolute number of patients for whom molecular profiling was successfully completed over the lifetime of the study
Secondary outcome [1] 377840 0
Proportion of screened patients enrolled
Timepoint [1] 377840 0
This is defined as the proportion of patients enrolled compared to those who were screened
Secondary outcome [2] 377841 0
Proportion of patients that successfully complete molecular profiling
Timepoint [2] 377841 0
This is defined as the proportion of patients for whom molecular profiling was successfully completed, as a proportion of those who were enrolled
Secondary outcome [3] 377842 0
Turn-around time (TAT) of molecular screening
Timepoint [3] 377842 0
This is defined as the time taken from patient consent to central receipt of a completed Molecular Tumour Board Report. In addition, the time from receipt of tumour tissue to a completed Molecular Tumour Board Report will also be measured
Secondary outcome [4] 377843 0
Matching of Molecular Tumour Board recommendations with pharmaceutical agents. Results from the Molecular Tumour Board Report will be reviewed by a panel of experts who will make recommendations based on the results of the molecular testing and these will be provided to the treating doctor.
Timepoint [4] 377843 0
This is the absolute number of patients with actionable mutations detected on molecular profiling with targeted agents, either through a clinical trial, compassionate access, hospital supply, or pharmaceutical access programmes
Secondary outcome [5] 377844 0
The proportion of patients in whom a Molecular Tumour Board recommended pharmaceutical agent is obtained will be assessed through reporting of treatment and follow-up information to the LUMOS study by the treating physician at each instance that the participant comes in for a treatment visit or assessment. The treating doctor will discuss results from the Molecular Tumour Board Report with the participant and both will jointly decide which of the available treatments the participant wishes to undertake.

Timepoint [5] 377844 0
This is the proportion of patients in whom a pharmaceutical targeted agent is obtained and used, either through a clinical trial, compassionate access, hospital supply, or pharmaceutical access programmes
Secondary outcome [6] 377845 0
Response to any Molecular Tumour Board recommended pharmaceutical agent. The response to a recommended pharmaceutical agent will be measured by follow-up visits every two months for 24 months following delivery of the molecular tumour board report or as directed by the treating physician based on the schedule of the treatment received, clinical trial protocol, special access scheme, or standard of care at site. At each follow-up visit, a clinic assessment, blood tests and an MRI will be performed to assess response to pharmaceutical agents. If the patient transfers to another site for treatment, then follow-up information (including MRI results) will be captured remotely.
Timepoint [6] 377845 0
Key clinical outcomes (response and duration of response, time to progression, overall survival as measured by Progression Free Survival at 12 months) will be measured by follow-up visits every two months for 24 months following delivery of the molecular tumour board report or as directed by the treating physician based on the schedule of the treatment received, clinical trial protocol, special access scheme or standard of care at site. At each follow-up visit, a clinic assessment, blood tests and an MRI will be performed to assess response to pharmaceutical agents.
Secondary outcome [7] 377846 0
Number of patients who undergo further surgical debulking at time of disease progression whilst participating in LUMOS
Timepoint [7] 377846 0
This is the number of patients participating in LUMOS who are deemed suitable for second debulking surgery at the time of disease progression. This is at the discretion of the Treating Physician. Follow-up visits to assess progression to disease will be performed every two months for 24 months following delivery of the molecular tumour board report or as directed by the treating physician based on the schedule of the treatment received, clinical trial protocol, special access scheme or standard of care at site. At each follow-up visit, a clinic assessment, blood tests, and an MRI will be performed. Follow-up information will be reported for the LUMOS study.
Secondary outcome [8] 377847 0
The number of patients who were screened for the study
Timepoint [8] 377847 0
This is the number of patients screened to confirm eligibility for the study
Secondary outcome [9] 378704 0
Response to clinician recommended pharmaceutical agent
Timepoint [9] 378704 0
Key clinical outcomes (response and duration of response, time to progression, overall survival as measured by Progression Free Survival at 12 months) will be recorded.

Eligibility
Key inclusion criteria
1. Adults, aged 18 years and older, with histological confirmed grade 2 or 3 glioma at initial diagnosis.
2. Prior to last craniotomy and surgery, evidence of progressive disease as defined as evidence of new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy.
3. Has available tissue from resection for progressive disease for molecular profiling either within 6 months of study enrolment or following enrolment.
4. For patients who are undergoing standard of care surgery at the time of study entry:
a. The patient must be suitable for craniotomy as the opinion of the neurosurgical team who will perform the surgery.
b. In the opinion of the neurosurgical team, it will be possible to safely undertake a debulking procedure and that sufficient tissue will be obtained for molecular testing
c. Has substantially recovered from their surgical resection, as evidenced by having no major on-going safety issues (e.g. infection requiring antibiotics)
5. Patients who have already undergone standard of care surgery less than or equal to 6 months prior to study registration, there must be sufficient tissue available for molecular testing and the patient must not have had intervening anti-cancer therapy.
6. Dose at registration must be less than or equal to 20mg prednisolone or less than or equal to 3 mg dexamethasone daily (or equivalent). Patients who are not on steroids are preferred for study participation.
7. ECOG performance status 0-2.
8. Has measurable disease post their last craniotomy that is suitable for repeat assessment by MRI scans.
9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
10. Signed, written informed consent (main study and tissue banking).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Glioma tissue for molecular pathology obtained greater than or equal to 6 months prior to study entry
2. Any intervening systemic therapy or radiotherapy between most recent imaging showing progressive disease and study enrolment
3. Patients who have had intra-surgical treatments (e.g. oncolytic virus administration, Gliadel wafers) at their last craniotomy prior to study enrolment
4. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
5. Subjects unable (e.g. due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head.
6. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a pilot study and no formal sample size calculation was undertaken. It is expected that the pilot will contain 5 sites and approximately 10 patients in the 12 months period.

The following variables will be presented using standard summary statistics. No formal statistical analysis is planned.
Recruitment:
• The number of eligible grade 2/3 glioma patients will be obtained from site screening logs and described separately at each site and overall.
• The number and percentage of these patients who are enrolled on LUMOS will be described separately at each site and overall.
• Demographic and clinical characteristics of enrolled patients will be summarised.
Molecular screening:
• The number and percentage of enrolled patients for whom tissue was successfully screened using molecular profiling
• Reasons for not undergoing molecular screening and for unsuccessful screening.
• In patients for whom a molecular screening report is received, the median (range) time from time of consent and from time that laboratory received the tissue, to the time of receipt of the report by the Treating Physician.
• In patients for whom a molecular screening report is received, number of targets identified that match molecular targeted agents currently accessible through clinical trials or pharmaceutical access programs.
• In patients for whom a target was identified, whether or not treatment plan was subsequently changed, and reasons for changing/not changing the plan.
• In patients for whom a target was identified, the proportion who received a targeted agents as a result of the MTB recommendation
Clinical outcomes:
• The number and percentage of enrolled patients who experience disease progression while participating on LUMOS, and the number and percentage of these who then undergo further debulking
• The number and percentage of patients who achieve tumour response, and the median (range) duration of response
• Overall and progression-free survival will be described using the Kaplan-Meier method

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)
NSW,QLD,WA,VIC
Recruitment hospital [1] 15446 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 15447 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 17453 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [4] 17701 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 17702 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 28796 0
3084 - Heidelberg
Recruitment postcode(s) [2] 28797 0
3000 - Melbourne
Recruitment postcode(s) [3] 31181 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 31555 0
4029 - Herston
Recruitment postcode(s) [5] 31556 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 304496 0
Government body
Name [1] 304496 0
Medical Research Future Fund
Address [1] 304496 0
Sirius Building, 23 Furzer Street, Woden Town Centre, ACT 2606
Country [1] 304496 0
Australia
Primary sponsor type
University
Name
NHMRC Clinical Trials Centre (CTC), University of Sydney
Address
The University of Sydney (USYD), City Rd, Darlington New South Wales 2008
Country
Australia
Secondary sponsor category [1] 306137 0
None
Name [1] 306137 0
Address [1] 306137 0
Country [1] 306137 0
Other collaborator category [1] 281309 0
Other Collaborative groups
Name [1] 281309 0
Cooperative Trials Group for Neuro-Oncology
Address [1] 281309 0
NHMRC Clinical Trials Centre
Level 6, Lifehouse
119-143 Missenden Road
Camperdown, NSW 2050
Country [1] 281309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304929 0
Royal Prince Alfred Hospital Ethics committee
Ethics committee address [1] 304929 0
Suite 210A
RPA Medical Centre
Cnr Missenden Road and Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 304929 0
Australia
Date submitted for ethics approval [1] 304929 0
16/09/2019
Approval date [1] 304929 0
27/11/2019
Ethics approval number [1] 304929 0
X19-0383 and 2019/ETH12848

Summary
Brief summary
This study aims to evaluate a new approach to provide a ‘personalised’ treatment management plan for patients with glioma that has started to grow again following treatment with radiotherapy and chemotherapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older, with histological confirmed grade 2 or 3 glioma at initial diagnosis. In addition, evidence of progressive disease as defined as evidence of new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy.

Study details
For each participant, the study will involve a taking a sample of tumour tissue during surgery and then screened for a range of biomarkers. If a suitable biomarker is found, the study team will try and match the identified biomarker with specific treatment. Blood samples and imaging assessments will also be obtained during this study.

It is hoped that screening tumour tissue for specific biomarkers can inform a personalised treatment plan for patients with brain cancer and provide valuable insight to the feasibility of conducting such trials.
Trial website
https://www.cogno.org.au/content.aspx?page=currenttrials
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98670 0
Prof Hui Gan
Address 98670 0
NHMRC Clinical Trials Centre
The Lifehouse Building, Level 6,
119-143 Missenden Road
Camperdown, NSW, 2050
Country 98670 0
Australia
Phone 98670 0
+61 2 9562 5000
Fax 98670 0
Email 98670 0
lumos@ctc.usyd.edu.au
Contact person for public queries
Name 98671 0
Dr LUMOS Trial Operations Coordinator
Address 98671 0
NHMRC Clinical Trials Centre
The Lifehouse Building, Level 6,
119-143 Missenden Road
Camperdown, NSW, 2050
Country 98671 0
Australia
Phone 98671 0
+61 2 9562 5000
Fax 98671 0
Email 98671 0
lumos@ctc.usyd.edu.au
Contact person for scientific queries
Name 98672 0
Dr LUMOS Trial Operations Coordinator
Address 98672 0
NHMRC Clinical Trials Centre
The Lifehouse Building, Level 6,
119-143 Missenden Road
Camperdown, NSW, 2050
Country 98672 0
Australia
Phone 98672 0
+61 2 9562 5000
Fax 98672 0
Email 98672 0
lumos@ctc.usyd.edu.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