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Trial registered on ANZCTR


Registration number
ACTRN12611000212954
Ethics application status
Approved
Date submitted
27/10/2010
Date registered
28/02/2011
Date last updated
28/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck
Scientific title
A randomised trial of postoperative radiation therapy following wide excision of neurotropic melanoma of the head and neck to compare rate and timing of local relapse
Secondary ID [1] 904 0
None
Universal Trial Number (UTN)
Trial acronym
RTN2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutropic Melanoma of Head and Neck 237083 0
Condition category
Condition code
Cancer 237405 237405 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical excision of melanoma - this will occur before patient is recruited to trial.
Radiation - Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local relapse. This will be at a dose of 48Gy in 20 fractions.
Observation of affected area will be once every 3 months for the first 2 years, then every 6 months for the next 3 years.

Follow up frequency and overall duration for the observational arm is the same as for the radiation arm ie once every 3 motnhs for the first 2 years and then every 6 months for the next 3 years
Intervention code [1] 236802 0
Treatment: Surgery
Intervention code [2] 257488 0
Treatment: Other
Comparator / control treatment
Observation
Control group
Active

Outcomes
Primary outcome [1] 259515 0
The primary objective of the trial is to determine, in patients who have undergone surgery with curative intent for neurotropic melanoma, whether there is a difference in the rate and timing of local relapse between patients who are treated with post-operative radiation therapy and those that are initially observed.
Timepoint [1] 259515 0
Time to local relapse after treatment
Secondary outcome [1] 266125 0
To determine, in these patients, whether there is a difference in relapse-free survival, patterns of relapse and overall survival between patients treated with surgery alone and those treated by surgery plus adjuvant radiation therapy.

Observation Arm:

14 weeks following surgery
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Every 3 months after randomisation for 2 years
- ECOG status
- Clinical Examination
- Quality of Life questionnaire will be performed at every 6 monthly assessment


Every six months for 3 years (total of 5 years from randomisation)
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

The following assessments will also be conducted at each 12 monthly follow-up visit:
- ECOG status
- Full blood count and differential (FBE)
- Urea, creatinine and electrolytes (U&E)
- LFTs
- MRI of the head and neck
- CT chest or CXR chest

8.3.2 Radiotherapy Arm:

14 weeks following surgery
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Two weeks post radiotherapy treatment
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Six weeks post radiotherapy treatment
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Every 3 months after completion of radiotherapy treatment for 2 years
- ECOG status
- Clinical Examination
- Quality of Life questionnaire will be performed at every 6 monthly assessment


Every six months for 3 years (total of 5 years from randomisation)
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

The following assessments will also be conducted at each 12 monthly follow-up visit:
- ECOG status
- Full blood count and differential (FBE)
- Urea, creatinine and electrolytes (U&E) LFTs
- MRI of the head and neck
- CT chest or CXR chest
Timepoint [1] 266125 0
Outcome measured after treatment
Secondary outcome [2] 266126 0
To determine, in these patients, whether there is a difference in morbidity and quality of life between patients treated with surgery alone and those treated with surgery plus adjuvant radiation therapy.

Observation Arm:

- 14 weeks following surgery
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Every 3 months after randomisation for 2 years
- ECOG status
- Clinical Examination
- Quality of Life questionnaire will be performed at every 6 monthly assessment


Every six months for 3 years (total of 5 years from randomisation)
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

The following assessments will also be conducted at each 12 monthly follow-up visit:
- ECOG status
- Full blood count and differential (FBE)
- Urea, creatinine and electrolytes (U&E), LFTs
- MRI of the head and neck
- CT chest or CXR chest

8.3.2 Radiotherapy Arm:

14 weeks following surgery
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Two weeks post radiotherapy treatment
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Six weeks post radiotherapy treatment
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

Every 3 months after completion of radiotherapy treatment for 2 years
- ECOG status
- Clinical Examination
- Quality of Life questionnaire will be performed at every 6 monthly assessment


Every six months for 3 years (total of 5 years from randomisation)
- ECOG status
- Clinical Examination
- Quality of Life questionnaire

The following assessments will also be conducted at each 12 monthly follow-up visit:
- ECOG status
- Full blood count and differential (FBE)
- Urea, creatinine and electrolytes (U&E), LFTs
- MRI of the head and neck
- CT chest or CXR chest
Timepoint [2] 266126 0
Outcome measured after treatment

Eligibility
Key inclusion criteria
- Aged 18 years or older
- Has provided written informed consent for participation in this trial
- Histologically confirmed neurotropic primary melanoma
- 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 with negative microscopic margins
- No previous surgery for melanoma (other than complete macroscopic resection as stated above)
- No evidence of in-transit, nodal or distant metastases as determined by clinical examination, and any form of imaging
- 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
Gender
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 any form of imaging 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 greater than or equal to 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 greater than or equal to 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)
Patients are registered on trial by completing the registration and eligibility case report forms (CRFs) and forwarding by fax to the Trial Coordinating Centre. Online registration may be able to be performed in the future.
Prior to patient enrolment, the investigator should ensure that all of the following requirement are met:
- The patient meets all inclusion criteria and none of the exclusion criteria should apply
- The patient and investigator have signed and dated all applicable consent forms
- All baseline assessments and investigations have been performed
- The eligibility checklist has been completed, signed and dated

Following registration the Trial Coordinating Centre will conduct the randomisation procedures. Written notification of the randomisation arm will be sent by fax to the participating site for each registered patient.

The radnomisation arms will be as follows:
Arm A: Investigational Treatment - Radiation therapy after surgery
Arm B: Standard Treatment - Initial observation after surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
QLD

Funding & Sponsors
Funding source category [1] 257941 0
Other Collaborative groups
Name [1] 257941 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 257941 0
Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle Hospital
Locked Bag 7 HRMC NSW 2310
Country [1] 257941 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle Hospital
Locked Bag 7 HRMC NSW 2310
Country
Australia
Secondary sponsor category [1] 257138 0
Hospital
Name [1] 257138 0
Princess Alexandra Hospital
Address [1] 257138 0
199 Ipswich Road
Woolloongabba Qld 4102
Country [1] 257138 0
Australia
Other collaborator category [1] 251625 0
Other Collaborative groups
Name [1] 251625 0
Australia and New Zealand Melanoma Trials Group
Address [1] 251625 0
The Poche Centre
40 Rocklands Road
North Sydney, NSW 2060
Country [1] 251625 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259951 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 259951 0
Building 35
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba Qld 4102
Ethics committee country [1] 259951 0
Australia
Date submitted for ethics approval [1] 259951 0
13/02/2009
Approval date [1] 259951 0
03/03/2009
Ethics approval number [1] 259951 0
2009/039

Summary
Brief summary
This study looks at the effectiveness of the addition of radiotherapy to surgery on local relapse and survival in patients with neurotropic melanoma. Who is it for? You can join this study if you have neurotropic primary melanoma in the head or neck, and have had no previous surgery and you will be treated at Princess Alexandra Hospital in Queensland (Other sites around Australia will be opened within the next six months). Trial details Participants will be in two groups. Both groups will receive surgery to excise their melanomas, and then one group will be randomised to receive follow-up post-operative radiation therapy. The other group will be randomised to observation only after their surgery, with follow-up occurring every 3 months for the first 2 years, then every 6 months for the next 3 years. The aim of the study is to compare the local relapse rate, survival, side effects and quality of life between the two groups.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29789 0
Address 29789 0
Country 29789 0
Phone 29789 0
Fax 29789 0
Email 29789 0
Contact person for public queries
Name 13036 0
Janelle Meakin
Address 13036 0
Cancer Services Research Unit
Princess Alexandra Hospital
Level 2, Building 1
199 Ipswich Road
Woolloongabba Qld 4102
Country 13036 0
Australia
Phone 13036 0
+61 7 3176 2498
Fax 13036 0
+61 7 3176 2252
Email 13036 0
Janelle_Meakin@health.qld.gov.au
Contact person for scientific queries
Name 3964 0
Dr Matthew Foote
Address 3964 0
Cancer Services Research Unit
Princess Alexandra Hospital
Level 2, Building 1
199 Ipswich Road
Woolloongabba Qld 4102
Country 3964 0
Australia
Phone 3964 0
+ 61 7 3176 2111
Fax 3964 0
+ 61 7 3176 2252
Email 3964 0
Matthew_Foote@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results