Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00975520
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2009-09-10
Brief Title:
Neurotropic Melanoma of the Head and Neck
Sponsor:
Melanoma and Skin Cancer Trials Limited
Organization:
Melanoma and Skin Cancer Trials Limited
Study Overview
Official Title:
A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTN2
Brief Summary:
This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin Radiation will commence within 3 months of surgery maximum of 14 weeks from surgery to start of radiotherapy
Detailed Description:
Background Melanoma is a serious and common malignancy in Australia It is the third most common cancer in Australia and approximately 1000 Australians will die of the disease each yearAt least a quarter of these will be patients under the age of 40 years
Neurotropism defined as invasion by melanoma of peripheral neural tissue is a feature of the disease that may predispose towards a high local recurrence rate Local recurrence particularly in the head and neck region often requires more extensive potentially morbid surgery Neurotropism is especially likely to occur in desmoplastic melanoma where it may be as high as 40 - 606-8 Desmoplastic melanoma tends to occur in a slightly older age group than conventional types of melanoma and most often occurs in the head and neck region in individuals with chronic sun damage
The management of localised neurotropic melanoma has traditionally been with surgery Recommendations are that surgical margins should be at least 2 cmThere are some patients where this margin is not achievable due to the location of the tumour close to important anatomical structures Uncontrolled studies suggest that radiation therapy may reduce the risk of local recurrence in those patients although there are no randomised trials to confirm this hypothesis
Postoperative adjuvant radiation therapy has been shown in a randomised trial led from Australia to reduce regional recurrence rates in nodal melanomaThere are no previously conducted randomised controlled trials addressing a similar question for neurotropic melanoma The only reports are in relation to retrospective reviews that suggest a benefit for postoperative radiation therapy after surgery It is unlikely that this trial will be done outside of Australia
Hypotheses
1 Radiation therapy after surgery for neurotropic melanoma improves local control
2 This can be achieved without a significant increase in treatment morbidity or reduction in quality of life
Primary Objective
To determine in patients who have undergone surgery with curative intent for neurotropic melanoma whether there is a difference in the rate and timing of local in field recurrence between patients who are treated with post-operative radiation therapy and those that are initially observed
Secondary Objectives
To determine in these patients whether there is a difference in progression-free survival patterns of relapse and overall survival between patients treated with surgery alone and those treated by surgery plus adjuvant radiation therapy
To determine in these patients whether there is a difference in morbidity and quality of life between patients treated with surgery alone and those treated with surgery plus adjuvant radiation therapy
Methodology This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism Patients who are eligible on the basis of the pathology of the completely excised melanoma will be offered the opportunity to take part in the trial Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin within 3 months of surgery The same regimen which was used in the nodal trial will be used in this study Patients in the observation arm who subsequently recur in field may be offered further surgery followed by radiation therapy
Randomisation Methods Patients will be randomised in the ratio of 11 between the two arms radiation therapy and no radiation therapy Allocation to the treatment arm will be stratified by institution and tumour site head or neck using randomly permuted blocks Patients who are eligible on the basis of their pathology of excised melanoma will be offered the opportunity to take part in the trial While males and females will both be considered equally for participation on the trial there is no way of knowing if the ratio will be 11
Neurotropism defined as invasion by melanoma of peripheral neural tissue is a feature of the disease that may predispose towards a high local recurrence rate Local recurrence particularly in the head and neck region often requires more extensive potentially morbid surgery Neurotropism is especially likely to occur in desmoplastic melanoma where it may be as high as 40 - 606-8 Desmoplastic melanoma tends to occur in a slightly older age group than conventional types of melanoma and most often occurs in the head and neck region in individuals with chronic sun damage
The management of localised neurotropic melanoma has traditionally been with surgery Recommendations are that surgical margins should be at least 2 cmThere are some patients where this margin is not achievable due to the location of the tumour close to important anatomical structures Uncontrolled studies suggest that radiation therapy may reduce the risk of local recurrence in those patients although there are no randomised trials to confirm this hypothesis
Postoperative adjuvant radiation therapy has been shown in a randomised trial led from Australia to reduce regional recurrence rates in nodal melanomaThere are no previously conducted randomised controlled trials addressing a similar question for neurotropic melanoma The only reports are in relation to retrospective reviews that suggest a benefit for postoperative radiation therapy after surgery It is unlikely that this trial will be done outside of Australia
Hypotheses
1 Radiation therapy after surgery for neurotropic melanoma improves local control
2 This can be achieved without a significant increase in treatment morbidity or reduction in quality of life
Primary Objective
To determine in patients who have undergone surgery with curative intent for neurotropic melanoma whether there is a difference in the rate and timing of local in field recurrence between patients who are treated with post-operative radiation therapy and those that are initially observed
Secondary Objectives
To determine in these patients whether there is a difference in progression-free survival patterns of relapse and overall survival between patients treated with surgery alone and those treated by surgery plus adjuvant radiation therapy
To determine in these patients whether there is a difference in morbidity and quality of life between patients treated with surgery alone and those treated with surgery plus adjuvant radiation therapy
Methodology This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism Patients who are eligible on the basis of the pathology of the completely excised melanoma will be offered the opportunity to take part in the trial Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin within 3 months of surgery The same regimen which was used in the nodal trial will be used in this study Patients in the observation arm who subsequently recur in field may be offered further surgery followed by radiation therapy
Randomisation Methods Patients will be randomised in the ratio of 11 between the two arms radiation therapy and no radiation therapy Allocation to the treatment arm will be stratified by institution and tumour site head or neck using randomly permuted blocks Patients who are eligible on the basis of their pathology of excised melanoma will be offered the opportunity to take part in the trial While males and females will both be considered equally for participation on the trial there is no way of knowing if the ratio will be 11
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN12610000478011 | REGISTRY | ANZCTR | None |
| 2009039 | OTHER | None | None |