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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00287196




Registration number
NCT00287196
Ethics application status
Date submitted
3/02/2006
Date registered
6/02/2006
Date last updated
25/06/2013

Titles & IDs
Public title
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Scientific title
Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
Secondary ID [1] 0 0
NHMRC 251732
Secondary ID [2] 0 0
TROG 02.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiotherapy

Active Comparator: Post-operative RADIOTHERAPY - Immediate post-operative RADIOTHERAPY

Experimental: Delayed Radiotherapy - OBSERVATION with delayed radiotherapy for relapse


Treatment: Other: Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Locoregional control
Timepoint [1] 0 0
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary outcome [3] 0 0
Toxicity
Timepoint [3] 0 0
Interim analysis will occur on annual basis.
Secondary outcome [4] 0 0
Quality of life
Timepoint [4] 0 0
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)

Eligibility
Key inclusion criteria
- Regional macroscopic nodal metastatic melanoma in one nodal basin region only which
has been completely resected.

- melanoma involving lymph nodes at high risk of local recurrence (details in protocol)

- No evidence of metastases

- No active major cancer within 5 years

- Normal blood tests

- WHO performance status of 0 or 1

- Radiotherapy must be able to be commenced within 12 weeks of lymphadenectomy

- Patient must not be pregnant and if fertile must use a medically acceptable
contraceptive throughout treatment

- No major concurrent illnesses likely to cause death within 2 years

- Written informed consent has been given
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of active or previous local recurrence or in transit disease

- Evidence of distant metastases on clinical or radiological investigation

- Patients with prior cancers

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Mater Hospital - North sydney - Crows Nest
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [8] 0 0
Mater QRI - South Brisbane
Recruitment hospital [9] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [13] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [14] 0 0
Alfred Hospital - Prahran
Recruitment hospital [15] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [16] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
1585 - Crows Nest
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4101 - South Brisbane
Recruitment postcode(s) [9] 0 0
4224 - Tugun
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
7250 - Launceston
Recruitment postcode(s) [12] 0 0
8006 - East Melbourne
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
3181 - Prahran
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo
Country [2] 0 0
Netherlands
State/province [2] 0 0
Groningen
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
New Zealand
State/province [5] 0 0
Dunedin
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University Medical Center Groningen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This trial seeks to establish the role of post-operative radiotherapy in patients who have
had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00287196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bryan Burmeister
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/ct2/show/NCT00287196