Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287196
• Other study ID #: TROG 02.01
• Secondary ID: NHMRC 251732ANZM
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2006
• Last updated: June 23, 2013
• Start date: March 2002
• Est. completion date: December 2011

Study information

• Verified date: September 2009
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymph Node Disease
• Lymphatic Diseases
• Malignant Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Mater Hospital - North sydney	Crows Nest	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Andrew Love Cancer Care Centre, Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Alfred Hospital	Prahran	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater QRI	South Brisbane	Queensland
Australia	East Coast Cancer Centre	Tugun	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
Brazil	Hospital do Cancer	Sao Paulo
Netherlands	Groningen University Hospital	Groningen
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Wellington Hospital	Wellington

Sponsors (3)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Australian and New Zealand Intensive Care Society Clinical Trials Group, University Medical Center Groningen

Countries where clinical trial is conducted

Australia,  Brazil,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control		Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)	No
Secondary	Disease-free survival		Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)	No
Secondary	Overall survival		Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)	No
Secondary	Toxicity		Interim analysis will occur on annual basis.	Yes
Secondary	Quality of life		Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial)	No

External Links

•   Click here for more information about this study on the TROG official website