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

February 3, 2006
June 23, 2013
March 2002
November 2008   (final data collection date for 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) ] [ Designated as safety issue: No ]
Locoregional control
Complete list of historical versions of study NCT00287196 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disease-free survival
  • Overall survival
  • Toxicity
  • Quality of life
Not Provided
Not Provided
 
Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Melanoma
  • Lymph Node Disease
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
  • Active Comparator: Post-operative RADIOTHERAPY
    Immediate post-operative RADIOTHERAPY
    Intervention: Radiation: Radiotherapy
  • Experimental: Delayed Radiotherapy
    OBSERVATION with delayed radiotherapy for relapse
    Intervention: Radiation: Radiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2011
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Netherlands,   New Zealand
 
NCT00287196
TROG 02.01, NHMRC 251732, ANZMTG 01.02
No
Trans-Tasman Radiation Oncology Group (TROG)
Trans-Tasman Radiation Oncology Group (TROG)
  • University Medical Centre Groningen
  • Australian and New Zealand Intensive Care Society Clinical Trials Group
Study Chair: Bryan Burmeister Princess Alexandra Hospital
Trans-Tasman Radiation Oncology Group (TROG)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP