Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

NCT00287196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-06-25

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma
  • Lymph Node Disease

Interventions

RADIATION

Radiotherapy

48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER
  • Australian and New Zealand Intensive Care Society Clinical Trials Group

    collaborator NETWORK
  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Bryan Burmeister · Princess Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2008-11-30
Completion
2011-12-31

Countries

  • Australia
  • Brazil
  • Netherlands
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287196 on ClinicalTrials.gov