Malignant MelanomaPhase 3NCT00287196
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
A Phase 3 study testing Radiotherapy in people with Malignant Melanoma and Lymph Node Disease, run by Trans Tasman Radiation Oncology Group at 22 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Lymph Node Disease
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Mar 2002to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Evidence of active or previous local recurrence or in transit disease
- Evidence of distant metastases on clinical or radiological investigation
- Patients with prior cancers
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Australia16 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Mater Hospital - North sydney
Crows Nest, New South Wales, 1585
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 8006
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane Hospital
Herston, Queensland, 4029
Launceston General Hospital
Launceston, Tasmania, 7250
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Royal Perth Hospital
Perth, Western Australia, 6000
Alfred Hospital
Prahran, Victoria, 3181
Prince of Wales Hospital
Randwick, New South Wales, 2031
Mater QRI
South Brisbane, Queensland, 4101
East Coast Cancer Centre
Tugun, Queensland, 4224
Westmead Hospital
Wentworthville, New South Wales, 2145
New Zealand4 sites
Auckland Hospital
Auckland, 1001
Christchurch Hospital
Christchurch, 4710
Dunedin Hospital
Dunedin
Wellington Hospital
Wellington, 7902
About this study
Official title: Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
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.
Read the detailed description
This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.
- Conditions
- Malignant Melanoma, Lymph Node Disease
- Being tested
- Radiotherapy
- Keywords
- Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema
- Medical subject headings
- Melanoma, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Radiation
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Post-operative RADIOTHERAPY | Active comparator | Immediate post-operative RADIOTHERAPY Receives: Radiation: Radiotherapy |
| Delayed Radiotherapy | Experimental | OBSERVATION with delayed radiotherapy for relapse Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control
Measured: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary outcomes (4)
Disease-free survival
Measured: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Overall survival
Measured: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Toxicity
Measured: Interim analysis will occur on annual basis.
Quality of life
Measured: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startMar 2002
- Primary completionNov 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Bryan Burmeister, Study chair, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287196
- Sponsor's protocol ID
- TROG 02.01
- Other IDs
- NHMRC 251732, ANZMTG 01.02
- Status last verified
- Sep 2009
- First submitted
- 3 Feb 2006
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1049-1060. doi: 10.1016/S1470-2045(15)00187-4. Epub 2015 Jul 20.
PubMed 26206146Burmeister BH, Henderson MA, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma: a randomised trial. Lancet Oncol. 2012 Jun;13(6):589-97. doi: 10.1016/S1470-2045(12)70138-9. Epub 2012 May 9.
PubMed 22575589
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00287196
- Acronym / sponsor ID
- TROG 02.01
- Conditions
- Malignant Melanoma, Lymph Node Disease
- Keywords
- Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group
- Study start
- Mar 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomised phase III trial which is being performed on patients at high risk of local recurrence after having a lymphadenectomy for stage 3 melanoma. The control arm is surgery alone with radiotherapy reserved for those who recur. The study arm is surgery plus post-operative radiotherapy. All 3 major node sites are eligible. The radiation dose administered is 48Gy in 20 fractions. It is likely to be the only study of its kind ever performed. The target is 230 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative RADIOTHERAPY | Active comparator | Radiation: RadiotherapyImmediate post-operative RADIOTHERAPY |
| Delayed Radiotherapy | Experimental | Radiation: RadiotherapyOBSERVATION with delayed radiotherapy for relapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Evidence of active or previous local recurrence or in transit disease
- Evidence of distant metastases on clinical or radiological investigation
- Patients with prior cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: Radiation48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days. | Radiation | Delayed Radiotherapy, Post-operative RADIOTHERAPY |
Primary outcome
Locoregional control
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
4 secondary outcomes
Disease-free survival
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Overall survival
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Toxicity
Time frame: Interim analysis will occur on annual basis.
Quality of life
Time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 26206146Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1049-1060. doi: 10.1016/S1470-2045(15)00187-4. Epub 2015 Jul 20.
- Derived from this study: PubMed 22575589Burmeister BH, Henderson MA, Ainslie J, Fisher R, Di Iulio J, Smithers BM, Hong A, Shannon K, Scolyer RA, Carruthers S, Coventry BJ, Babington S, Duprat J, Hoekstra HJ, Thompson JF. Adjuvant radiotherapy versus observation alone for patients at risk of lymph-node field relapse after therapeutic lymphadenectomy for melanoma: a randomised trial. Lancet Oncol. 2012 Jun;13(6):589-97. doi: 10.1016/S1470-2045(12)70138-9. Epub 2012 May 9.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Burmeister study chair
Princess Alexandra Hospital
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy in people with Malignant Melanoma and Lymph Node Disease, run by Trans Tasman Radiation Oncology Group at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia, New Zealand, Brazil, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (time frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00287196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.