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Trial registered on ANZCTR


Registration number
ACTRN12614000491662
Ethics application status
Approved
Date submitted
11/03/2014
Date registered
12/05/2014
Date last updated
12/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Cetuximab Radiolabelled with Gallium-68, Lutetium-177 or Rhenium-188 as a Novel Radioimmunotherapy for Advanced Head and Neck Cancer: A New Adjunct to Multi-modality Treatment.
Scientific title
For patients with advanced head and neck squamous cell carcinoma, does Cetuximab Radiolabelled with Gallium-68, Lutetium-177 or Rhenium-188 exhibit tumour uptake relative to background sufficiently to enable targeted radioimmunotherapy?
Secondary ID [1] 284202 0
Nil
Universal Trial Number (UTN)
U1111-1154-0912
Trial acronym
The ReCHANCE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 291307 0
Condition category
Condition code
Cancer 291660 291660 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A theranostic micro dosing trial of gallium-68-DOTA-Cetuximab as a scouting radionuclide for tumour uptake with the potential for therapeutic Rhenium-188-DOTA-Cetuximab or Lutetium-177-DOTA-Cetuximab radioimmunotherapy.

Administration of all targeted diagnostic molecular imaging is via intravenous infusion. Each patient radiopharmaecutical dose is personalised and will be radio labelled to a Cetuximab dose range of 20 to 100mg as follows:

(a) for diagnostic molecular imaging:

- Gallium-68 dose activity escalation from 50MBq according to dose estimation as a SINGLE precursor scouting study.

(b) for theranostic progression to treatment:

- Rhenium-188 dose activity escalation from 500 MBq according to dose estimation.
- Lutetium-188 dose activity escalation from 500 MBq according to dose estimation.
- Frequency of targeted radioimmunotherapy is to be personalised according to patient response. If there is response to treatment, outpatient intravenous administration can be continued as a monthly dose. Treatment will continue until disease progression or if there is evidence of unacceptable toxicity.
Intervention code [1] 288899 0
Treatment: Other
Intervention code [2] 289270 0
Diagnosis / Prognosis
Intervention code [3] 289271 0
Treatment: Drugs
Comparator / control treatment
Advanced head and neck cancer patients from Fremantle Hospital Head and Neck Unit between 2003 and 2013. Patients in the control cohort are palliated with standard and varied palliative treatments including chemotherapy or external beam radiotherapy without curative intent.
Control group
Historical

Outcomes
Primary outcome [1] 291588 0
tumour uptake as measured by Single-photon emission computed tomography
Timepoint [1] 291588 0
At 1 hour, 6 hours and 24 hours
Primary outcome [2] 291589 0
If progressing to therapeutic delivery of Rhenium-188 or Lutetium-177 radio labelled with Cetuximab and in addition to analysing tumour uptake, to additionally assess radiological evidence of disease regression or progression via computed tomography
Timepoint [2] 291589 0
1 week, 1 month, 2 months
Secondary outcome [1] 307130 0
to measure progression free survival.
Timepoint [1] 307130 0
measured in months with initial patient review monthly for 6 months then 3 monthly for 1 year and biannually thereafter with an endpoint of 3 years.
Secondary outcome [2] 307131 0
to measure overall survival
Timepoint [2] 307131 0
measured in months with initial patient review monthly for 6 months then 3 monthly for 1 year and biannually thereafter with an endpoint of 3 years.

Eligibility
Key inclusion criteria
Histological evidence of head and neck squamous cell carcinoma.
Disease progression without option for further surgery or radiotherapy (palliation).
Able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Option for further radiotherapy or salvage surgery
Non-squamous cell carcinoma head and neck cancer

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



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical techniques:
Measurement: observational and experimental
Level of measurement: Quantitative and categorical
Methods:
Parametric and non-parametric methods for statistical analysis
Experimental quantitative algorithmic measurement of human biodistribution via analysis of F18-FDG-PET-CT and radionuclide bound-Cetuximab-SPECT-CT and PET-CT imaging.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2182 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 288868 0
Hospital
Name [1] 288868 0
Fremantle Hospital
Country [1] 288868 0
Australia
Funding source category [2] 288869 0
Charities/Societies/Foundations
Name [2] 288869 0
The Garnett Passe and Rodney Williams Memorial Foundation
Country [2] 288869 0
Australia
Funding source category [3] 288870 0
Charities/Societies/Foundations
Name [3] 288870 0
The Fremantle Hospital Medical Research Foundation
Country [3] 288870 0
Australia
Primary sponsor type
Individual
Name
Dr Timothy Marr
Address
Fremantle Hospital
Department of Otolaryngology, Head and Neck Surgery
Alma Street
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 287564 0
Individual
Name [1] 287564 0
Clinical Professor J. Harvey Turner
Address [1] 287564 0
Director of Nuclear Medicine
Fremantle Hospital
Department of Nuclear Medicine
Alma Street
Fremantle WA 6160
Country [1] 287564 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290697 0
The South Metropolital Health Service Human Research Ethics Committee
Ethics committee address [1] 290697 0
Research Governance and Ethics Office
Fremantle Hospital
PO BOX 480
Fremantle
WA 6959
Ethics committee country [1] 290697 0
Australia
Date submitted for ethics approval [1] 290697 0
Approval date [1] 290697 0
03/09/2013
Ethics approval number [1] 290697 0
13/9

Summary
Brief summary
This study is evaluating whether radiolabelled Cetuximab exhibits tumour uptake sufficiently to enable targeted radioimmunotherapy in patients with advanced head and neck cancer.
Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced head and neck squamous cell carcinoma, without option for further surgery or radiotherapy.
Study details: All participants in this study will undergo a precursor imaging study with gallium-68-cetuximab. If appropriate they will be offered salvage radioimmunotherapy with newly developed Rhenium-188-Cetuximab or Lutetium-177-Cetuximab using the tumour-targeting ability of Cetuximab to deliver internal radiation to the tumour. Follow up assessments will comprise standard-of-care imaging and blood testing. Given a favourable response, repeat radioimmunotherapy may be contemplated for subsequent relapse with either of the aforementioned beta emitting radionuclides.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46694 0
Dr Timothy Marr
Address 46694 0
Department of Nuclear Medicine
Fremantle Hospital
PO BOX 480
Fremantle WA 6959
Country 46694 0
Australia
Phone 46694 0
+61 8 9431 3333
Fax 46694 0
+61 8 9431 3310
Email 46694 0
[email protected]
Contact person for public queries
Name 46695 0
Timothy Marr
Address 46695 0
Department of Nuclear Medicine
Fremantle Hospital
PO BOX 480
Fremantle WA 6959
Country 46695 0
Australia
Phone 46695 0
+61 8 9431 3333
Fax 46695 0
Email 46695 0
[email protected]
Contact person for scientific queries
Name 46696 0
Timothy Marr
Address 46696 0
Department of Nuclear Medicine
Fremantle Hospital
PO BOX 480
Fremantle WA 6959
Country 46696 0
Australia
Phone 46696 0
+61 8 9431 3333
Fax 46696 0
Email 46696 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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