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Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Primary Purpose

Malignant Melanoma, Lymph Node Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Mater Hospital - North sydney
  • Calvary Mater Newcastle
  • Prince of Wales Hospital
  • Westmead Hospital
  • Princess Alexandra Hospital
  • Royal Brisbane Hospital
  • Mater QRI
  • East Coast Cancer Centre
  • Royal Adelaide Hospital
  • Launceston General Hospital
  • Peter MacCallum Cancer Centre
  • Andrew Love Cancer Care Centre, Geelong Hospital
  • Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Hospital do Cancer
  • Groningen University Hospital
  • Auckland Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Post-operative RADIOTHERAPY

Delayed Radiotherapy

Arm Description

Immediate post-operative RADIOTHERAPY

OBSERVATION with delayed radiotherapy for relapse

Outcomes

Primary Outcome Measures

Locoregional control

Secondary Outcome Measures

Disease-free survival
Overall survival
Toxicity
Quality of life

Full Information

First Posted
February 3, 2006
Last Updated
June 23, 2013
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00287196
Brief Title
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
Official Title
Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
University Medical Center Groningen, Australian and New Zealand Intensive Care Society Clinical Trials Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma, Lymph Node Disease
Keywords
Melanoma, Lymph node disease, Adjuvant radiotherapy, Lymphoedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-operative RADIOTHERAPY
Arm Type
Active Comparator
Arm Description
Immediate post-operative RADIOTHERAPY
Arm Title
Delayed Radiotherapy
Arm Type
Experimental
Arm Description
OBSERVATION with delayed radiotherapy for relapse
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiation
Intervention Description
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Primary Outcome Measure Information:
Title
Locoregional control
Time Frame
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Secondary Outcome Measure Information:
Title
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)
Title
Overall survival
Time Frame
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Title
Toxicity
Time Frame
Interim analysis will occur on annual basis.
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Burmeister
Organizational Affiliation
Princess Alexandra Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Mater Hospital - North sydney
City
Crows Nest
State/Province
New South Wales
ZIP/Postal Code
1585
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater QRI
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
East Coast Cancer Centre
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Andrew Love Cancer Care Centre, Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Hospital do Cancer
City
Sao Paulo
Country
Brazil
Facility Name
Groningen University Hospital
City
Groningen
Country
Netherlands
Facility Name
Auckland Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
7902
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26206146
Citation
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.
Results Reference
derived
PubMed Identifier
22575589
Citation
Burmeister 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.
Results Reference
derived
Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

Learn more about this trial

Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

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