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Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287196
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : June 25, 2013
Sponsor:
Collaborators:
University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Lymph Node Disease Radiation: Radiotherapy Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2002
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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 Name: 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 Name: Radiation


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. Overall survival [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ]
  3. Toxicity [ Time Frame: Interim analysis will occur on annual basis. ]
  4. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287196


Locations
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Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
University Medical Center Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators
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Study Chair: Bryan Burmeister Princess Alexandra Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier: NCT00287196    
Other Study ID Numbers: TROG 02.01
NHMRC 251732 ( Other Grant/Funding Number: NHMRC )
ANZMTG 01.02 ( Other Identifier: Austalian NewZealand Melanoma Trials Group )
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: September 2009
Keywords provided by Trans Tasman Radiation Oncology Group:
Melanoma
Lymph node disease
Adjuvant radiotherapy
Lymphoedema
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas