Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Trans Tasman Radiation Oncology Group

Status and phase: Completed; Phase 3

Conditions: Lymph Node Disease; Malignant Melanoma

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00287196

NHMRC 251732 (Other Grant/Funding Number)

ANZMTG 01.02 (Other Identifier)

TROG 02.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Post-operative RADIOTHERAPY

Active Comparator group

Description:

Immediate post-operative RADIOTHERAPY

Treatment:

Radiation: Radiotherapy

Delayed Radiotherapy

Experimental group

Description:

OBSERVATION with delayed radiotherapy for relapse

Treatment:

Radiation: Radiotherapy