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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
Date last updated
16/02/2023

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
Not applicable
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
This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery (maximum of 14 weeks from surgery to start of radiotherapy).
Trial website
https://clinicaltrials.gov/study/NCT00975520
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00975520