Clinical trial · Interventional
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
NCT00287196CI-TRIAL-00011027completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Disease | — | UNRESOLVED | — |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Post-operative RADIOTHERAPY
- description
- Immediate post-operative RADIOTHERAPY
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Delayed Radiotherapy
- description
- OBSERVATION with delayed radiotherapy for relapse
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Locoregional control
- timeFrame
- Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHenderson MA, Burmeister BH, 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 lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1049-1060. doi: 10.1016/S1470-2045(15)00187-4. Epub 2015 Jul 20. PMID 26206146
- DERIVEDBurmeister 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. PMID 22575589