Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes
This study is ongoing, but not recruiting participants.
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Collaborators:
University Medical Centre Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00287196
First received: February 3, 2006
Last updated: September 29, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma Lymph Node Disease |
Radiation: Radiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients With Completely Resected Macroscopic Nodal Metastatic Melanoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
lymphedema-distichiasis syndrome
MedlinePlus related topics:
Melanoma
U.S. FDA Resources
Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary Outcome Measures:
- Locoregional control [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-free survival [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Interim analysis will occur on annual basis. ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Final analysis will occur when all patients have had 1 year follow up. (approx. 7 years after start of trial) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 236 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Immediate post-operative RADIOTHERAPY
|
Radiation: Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Other Name: Radiation
|
|
Experimental: B
OBSERVATION with delayed radiotherapy for relapse
|
Radiation: Radiotherapy
48 Gy reference dose in 20 fractions at 5 fractions per week, with a maximum overall treatment time of 30 days.
Other Name: Radiation
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287196
Locations
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| Mater Hospital - North sydney | |
| Crows Nest, New South Wales, Australia, 1585 | |
| Calvary Mater Newcastle | |
| Newcastle, New South Wales, Australia, 2298 | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Westmead Hospital | |
| Wentworthville, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Princess Alexandra Hospital | |
| Brisbane, Queensland, Australia, 4102 | |
| Royal Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Mater QRI | |
| South Brisbane, Queensland, Australia, 4101 | |
| East Coast Cancer Centre | |
| Tugun, Queensland, Australia, 4224 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Tasmania | |
| Launceston General Hospital | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 8006 | |
| Andrew Love Cancer Care Centre, Geelong Hospital | |
| Geelong, Victoria, Australia, 3220 | |
| Alfred Hospital | |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Brazil | |
| Hospital do Cancer | |
| Sao Paulo, Brazil | |
| Netherlands | |
| Groningen University Hospital | |
| Groningen, Netherlands | |
| New Zealand | |
| Auckland Hospital | |
| Auckland, New Zealand, 1001 | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 4710 | |
| Dunedin Hospital | |
| Dunedin, New Zealand | |
| Wellington Hospital | |
| Wellington, New Zealand, 7902 | |
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
University Medical Centre Groningen
Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators
| Study Chair: | Bryan Burmeister | Princess Alexandra Hospital |
More Information
Additional Information:
No publications provided by Trans-Tasman Radiation Oncology Group (TROG)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Associate Professor Bryan Burmeister, Trans Tasman Radiation Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00287196 History of Changes |
| Other Study ID Numbers: | TROG 02.01, NHMRC 251732 |
| Study First Received: | February 3, 2006 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
|
Melanoma Lymph node disease Adjuvant radiotherapy Lymphoedema |
Additional relevant MeSH terms:
|
Melanoma Lymphatic Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 23, 2013