Know Cancer

or
forgot password

Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma, Lymph Node Disease

Thank you

Trial Information

Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Locoregional control

Outcome Time Frame:

Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)

Safety Issue:

No

Principal Investigator

Bryan Burmeister

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Alexandra Hospital

Authority:

Australia: Human Research Ethics Committee

Study ID:

TROG 02.01

NCT ID:

NCT00287196

Start Date:

March 2002

Completion Date:

December 2011

Related Keywords:

  • Malignant Melanoma
  • Lymph Node Disease
  • Melanoma
  • Lymph node disease
  • Adjuvant radiotherapy
  • Lymphoedema
  • Melanoma
  • Lymphatic Diseases

Name

Location