Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

This study has been completed.
Sponsor:
Collaborators:
University Medical Centre Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00287196
First received: February 3, 2006
Last updated: June 23, 2013
Last verified: September 2009
  Purpose

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 Intervention Phase
Malignant Melanoma
Lymph Node Disease
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Locoregional control [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Interim analysis will occur on annual basis. ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: March 2002
Study Completion Date: December 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287196

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Mater Hospital - North sydney
Crows Nest, New South Wales, Australia, 1585
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Mater QRI
South Brisbane, Queensland, Australia, 4101
East Coast Cancer Centre
Tugun, Queensland, Australia, 4224
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 8006
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Alfred Hospital
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Brazil
Hospital do Cancer
Sao Paulo, Brazil
Netherlands
Groningen University Hospital
Groningen, Netherlands
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Wellington, New Zealand, 7902
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
University Medical Centre Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators
Study Chair: Bryan Burmeister Princess Alexandra Hospital
  More Information

Additional Information:
No publications provided by Trans-Tasman Radiation Oncology Group (TROG)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00287196     History of Changes
Other Study ID Numbers: TROG 02.01, NHMRC 251732, ANZMTG 01.02
Study First Received: February 3, 2006
Last Updated: June 23, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Melanoma
Lymph node disease
Adjuvant radiotherapy
Lymphoedema

Additional relevant MeSH terms:
Melanoma
Lymphatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 30, 2014