Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

June 23, 2013 updated by: Trans Tasman Radiation Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Crows Nest, New South Wales, Australia, 1585
        • Mater Hospital - North Sydney
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater QRI
      • Tugun, Queensland, Australia, 4224
        • East Coast Cancer Centre
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Care Centre, Geelong Hospital
      • Prahran, Victoria, Australia, 3181
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Brazil
      • Sao Paulo, Brazil
        • Hospital do Câncer
  • Netherlands
      • Groningen, Netherlands
        • Groningen University Hospital
  • New Zealand
      • Auckland, New Zealand, 1001
        • Auckland Hospital
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Wellington, New Zealand, 7902
        • Wellington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post-operative RADIOTHERAPY
Immediate post-operative RADIOTHERAPY
Radiation: Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Other Names:
  • Radiation
Experimental: Delayed Radiotherapy
OBSERVATION with delayed radiotherapy for relapse
Radiation: Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Other Names:
  • Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Locoregional control
Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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.
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)
Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group

Investigators

  • Study Chair: Bryan Burmeister, Princess Alexandra Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 23, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 02.01
  • NHMRC 251732 (Other Grant/Funding Number: NHMRC)
  • ANZMTG 01.02 (Other Identifier: Austalian NewZealand Melanoma Trials Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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