Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000534482
Ethics application status
Approved
Date submitted
15/10/2007
Date registered
18/10/2007
Date last updated
1/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Study Investigating the Impact of Definitive Chemoradiation in Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin
Scientific title
A Prospective Nonrandomised Study Investigating the Impact of Definitive Chemoradiation Using Cisplatin or Carboplatin on Complete Response Rate in Patients with Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin
Secondary ID [1] 287974 0
nil known
Universal Trial Number (UTN)
Trial acronym
CRUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Skin 2464 0
Condition category
Condition code
Cancer 2565 2565 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cisplatin 40mg/m2 given intravenously once per week concurrent with radiation therapy for 6 weekly doses
Carboplatin at a dose of AUC2 given intravenously once a week for 6 weekly doses concurrent with radiotherapy, for patients where cisplatin is contraindicated
Intervention code [1] 2193 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3468 0
Complete Response Rate
Timepoint [1] 3468 0
8weeks after completion of therapy
Secondary outcome [1] 5787 0
Overall Survival
Timepoint [1] 5787 0
3years
Secondary outcome [2] 5788 0
Disease-free Survival
Timepoint [2] 5788 0
3years
Secondary outcome [3] 5789 0
Toxicity according to Common Toxicity Criteria Version 3.0
Timepoint [3] 5789 0
Acute toxicity monitored daily for the 7 weeks of radiation therapy, then at 4,8 & 12 weeks after completion of therapy. Late toxicity monitored every 2months for first year and every 3rd month for thereafter

Eligibility
Key inclusion criteria
Patients with cutaneous squamous cell carcinoma with locally-advanced disease at the primary site +/-nodal metastases, or advanced regional node metastases of presumed skin origin.
Disease deemed unsuitable for surgical resection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-morbid conditions precluding safe administration of trial therapy
Previous chemo- or radiotherapy to head and neck region precluding re-treatment
Pregnancy/lactation

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
26/01/2009
Date of last participant enrolment
Anticipated
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 283 0
4029

Funding & Sponsors
Funding source category [1] 2708 0
Self funded/Unfunded
Name [1] 2708 0
Country [1] 2708 0
Primary sponsor type
Individual
Name
Michelle Nottage
Address
Royal Brisbane and Women's Hospital
Herston Rd
Herston, 4029
Country
Australia
Secondary sponsor category [1] 2454 0
Individual
Name [1] 2454 0
Alessandra Francesconi
Address [1] 2454 0
Royal Brisbane and Women's Hospital
Herston Rd
Herston, 4029
Country [1] 2454 0
Australia
Other collaborator category [1] 72 0
Individual
Name [1] 72 0
Sabe Sabesan
Address [1] 72 0
Dept of Medical Oncology, Townsville Cancer Centre
Townsville Hospital
Country [1] 72 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4629 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 4629 0
Herston Rd
Herston
Ethics committee country [1] 4629 0
Australia
Date submitted for ethics approval [1] 4629 0
25/10/2007
Approval date [1] 4629 0
20/01/2008
Ethics approval number [1] 4629 0
Ethics committee name [2] 4630 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [2] 4630 0
Ethics committee country [2] 4630 0
Australia
Date submitted for ethics approval [2] 4630 0
25/11/2007
Approval date [2] 4630 0
Ethics approval number [2] 4630 0

Summary
Brief summary
Phase 2

This is a study of the effectiveness and toxicity of chemoradiation
therapy for skin cancer (squamous cell carcinoma).

Who is it for?
You can join this study if you have squamous cell skin cancer that
cannot be treated surgically.

Trial details
Participants will receive chemotherapy with the drugs cisplatin or carboplatin once per week for 6 weeks as well as daily radiotherapy. There is no
control group in this study. Participants' response to treatment will be
measured 8 weeks after treatment is completed. Side effects will be
monitored during treatment, at 4, 8 and 12 weeks after treatment is
completed, and then every 2 months for the first year, and every three
months after that. Overall survival and disease free survival will be
measured after 3 years.

The study aims to document the effectiveness and toxicity of treatment
with combined chemotherapy and radiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28118 0
Dr Michelle Nottage
Address 28118 0
Cancer Care services
Royal Brisbane and Women's Hospital
Herston
Queensland 4029
Country 28118 0
Australia
Phone 28118 0
61 7 36468111
Fax 28118 0
Email 28118 0
[email protected]
Contact person for public queries
Name 11275 0
Dr Dr Michelle K Nottage
Address 11275 0
Royal Brisbane and Women's Hospital
Herston Rd
Herston, 4029
Country 11275 0
Australia
Phone 11275 0
7 36368111
Fax 11275 0
Email 11275 0
[email protected]
Contact person for scientific queries
Name 2203 0
Dr Dr Michelle Nottage
Address 2203 0
Royal Brisbane and Women's Hospital
Herston Rd
Herston, 4029
Country 2203 0
Australia
Phone 2203 0
7 36368111
Fax 2203 0
Email 2203 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProspective study of definitive chemoradiation in locally or regionally advanced squamous cell carcinoma of the skin.2017https://dx.doi.org/10.1002/hed.24662
N.B. These documents automatically identified may not have been verified by the study sponsor.