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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00975520




Registration number
NCT00975520
Ethics application status
Date submitted
10/09/2009
Date registered
11/09/2009

Titles & IDs
Public title
Neurotropic Melanoma of the Head and Neck
Scientific title
A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
Secondary ID [1] 0 0
2009/039
Secondary ID [2] 0 0
01.09
Universal Trial Number (UTN)
Trial acronym
RTN2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Observation
Treatment: Other - Radiation Therapy

Active comparator: Radiation Therapy - Investigational Treatment

Other: Observation - Observation


Other interventions: Observation
Patients will be observed after surgery until recurrence when they will be offered radiation therapy

Treatment: Other: Radiation Therapy
Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local recurrence. The recommended dose prescribed is 48 Gy in 20 fractions over 4 weeks.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to local relapse
Timepoint [1] 0 0
5 years from the date of randomisation
Secondary outcome [1] 0 0
Relapse free survival
Timepoint [1] 0 0
5 years from date of randomisation
Secondary outcome [2] 0 0
Time to Relapse
Timepoint [2] 0 0
5 years from date of randomisation
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
5 years from date of randomisation
Secondary outcome [4] 0 0
Cancer specific survival
Timepoint [4] 0 0
5 years from date of randomisation
Secondary outcome [5] 0 0
Patterns of relapse
Timepoint [5] 0 0
5 years from date of randomisation
Secondary outcome [6] 0 0
Late Toxicity
Timepoint [6] 0 0
5 years from date of randomisation

Eligibility
Key inclusion criteria
* Aged 18 years or older
* Has provided written informed consent for participation in this trial
* Histologically confirmed neurotropic primary melanoma

* Neurotropism is identified pathologically by the presence of melanoma cells around nerve sheaths (perineural invasion) or within nerves (intraneural invasion).
* Occasionally, the tumour itself may form neuroid structures (termed 'neural transformation'; this is also regarded as neurotropism)
* "normal"-looking nerves that appear to be "entrapped" within the tumour should not be regarded as neurotropism
* Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)
* Complete macroscopic resection of all known disease
* No previous surgery for melanoma (other than complete macroscopic resection as stated above)(i.e. Not recurrent disease)
* No evidence of in-transit, nodal or distant metastases as determined by clinical examination, CT or MRI
* ECOG performance status score of 2 or less
* Life expectancy greater than 6 months
* Patients capable of childbearing are using adequate contraception
* Available for follow up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or lactating
* Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition
* Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour
* Inability to localise surgical bed on CT scans and/or surgical margins (cm) not known
* Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed
* High risk for poor compliance with therapy or follow-up as assessed by investigator
* Patients with prior cancers, except: those diagnosed = 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas = 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix
* Albinism
* Participation in other clinical trials with the same primary endpoint

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [2] 0 0
Melanoma Institute Australia / Royal Prince Alfred Hospital - North Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [6] 0 0
Radiation Oncology Services - Mater Centre - South Brisbane
Recruitment hospital [7] 0 0
Radiation Oncology Queensland (ROQ) - Toowoomba
Recruitment hospital [8] 0 0
Townsville Cancer Centre - Townsville
Recruitment hospital [9] 0 0
Genesis Care: Tugun - Tugun
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [13] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
- Toowoomba
Recruitment postcode(s) [8] 0 0
- Townsville
Recruitment postcode(s) [9] 0 0
4224 - Tugun
Recruitment postcode(s) [10] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
8006 - East Melbourne
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
Melanoma and Skin Cancer Trials Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Foote
Address 0 0
Princess Alexandra Hospital
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not sharing IPD


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00975520