Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT00975520
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2009-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurotropic Melanoma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to local relapse', 'timeFrame': '5 years from the date of randomisation'}], 'secondaryOutcomes': [{'measure': 'Relapse free survival', 'timeFrame': '5 years from date of randomisation'}, {'measure': 'Time to Relapse', 'timeFrame': '5 years from date of randomisation'}, {'measure': 'Overall survival', 'timeFrame': '5 years from date of randomisation'}, {'measure': 'Cancer specific survival', 'timeFrame': '5 years from date of randomisation'}, {'measure': 'Patterns of relapse', 'timeFrame': '5 years from date of randomisation'}, {'measure': 'Late Toxicity', 'timeFrame': '5 years from date of randomisation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurotropic', 'Melanoma', 'Observation', 'Radiation Therapy', 'Relapse'], 'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.masc.org.au/', 'label': 'Please visit this website for further trial specific information'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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 year.At least a quarter of these will be patients under the age of 40 years.\n\nNeurotropism, 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 - 60%.6-8 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.\n\nThe management of localised neurotropic melanoma has traditionally been with surgery. Recommendations are that surgical margins should be at least 2 cm.There 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.\n\nPostoperative adjuvant radiation therapy has been shown in a randomised trial led from Australia, to reduce regional recurrence rates in nodal melanoma.There 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.\n\nHypotheses\n\n1. Radiation therapy after surgery for neurotropic melanoma improves local control.\n2. This can be achieved without a significant increase in treatment morbidity or reduction in quality of life.\n\nPrimary Objective\n\n• 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.\n\nSecondary Objectives\n\n* 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.\n* 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\n\nMethodology 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.\n\nRandomisation Methods Patients will be randomised in the ratio of 1:1 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 1:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Has provided written informed consent for participation in this trial\n* Histologically confirmed neurotropic primary melanoma\n\n * Neurotropism is identified pathologically by the presence of melanoma cells around nerve sheaths (perineural invasion) or within nerves (intraneural invasion).\n * Occasionally, the tumour itself may form neuroid structures (termed \'neural transformation\'; this is also regarded as neurotropism)\n * "normal"-looking nerves that appear to be "entrapped" within the tumour should not be regarded as neurotropism\n* Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)\n* Complete macroscopic resection of all known disease\n* No previous surgery for melanoma (other than complete macroscopic resection as stated above)(i.e. Not recurrent disease)\n* No evidence of in-transit, nodal or distant metastases as determined by clinical examination, CT or MRI\n* ECOG performance status score of 2 or less\n* Life expectancy greater than 6 months\n* Patients capable of childbearing are using adequate contraception\n* Available for follow up\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition\n* Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour\n* Inability to localise surgical bed on CT scans and/or surgical margins (cm) not known\n* Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed\n* High risk for poor compliance with therapy or follow-up as assessed by investigator\n* Patients with prior cancers, except: those diagnosed ≥ 5 years ago with no evidence of disease relapse and clinical expectation of relapse of less than 5%; prior successfully treated Level 1 cutaneous melanomas ≥ 2 years ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix\n* Albinism\n* Participation in other clinical trials with the same primary endpoint'}, 'identificationModule': {'nctId': 'NCT00975520', 'acronym': 'RTN2', 'briefTitle': 'Neurotropic Melanoma of the Head and Neck', 'organization': {'class': 'OTHER', 'fullName': 'Melanoma and Skin Cancer Trials Limited'}, 'officialTitle': 'A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck', 'orgStudyIdInfo': {'id': '01.09'}, 'secondaryIdInfos': [{'id': '2009/039', 'type': 'OTHER', 'domain': 'HREC'}, {'id': 'ACTRN12610000478011', 'type': 'REGISTRY', 'domain': 'ANZCTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation Therapy', 'description': 'Investigational Treatment', 'interventionNames': ['Radiation: Radiation Therapy']}, {'type': 'OTHER', 'label': 'Observation', 'description': 'Observation', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'otherNames': ['Surgery Alone'], 'description': 'Patients will be observed after surgery until recurrence when they will be offered radiation therapy', 'armGroupLabels': ['Observation']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['RT, radiotherapy'], 'description': 'Patients randomised to the Investigational treatment arm, will receive adjuvant curative post-operative radiation therapy aiming to reduce the rate of local recurrence. The recommended dose prescribed is 48 Gy in 20 fractions over 4 weeks.', 'armGroupLabels': ['Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Ketttering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2310', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2060', 'city': 'North Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Melanoma Institute Australia / Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.839, 'lon': 151.2072}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane and Womens Hospital', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Radiation Oncology Services - Mater Centre', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Radiation Oncology Queensland (ROQ)', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'city': 'Townsville', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Townsville Cancer Centre', 'geoPoint': {'lat': -19.26639, 'lon': 146.80569}}, {'zip': '4224', 'city': 'Tugun', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Genesis Care: Tugun', 'geoPoint': {'lat': -28.15, 'lon': 153.5}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '8006', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hosptial, NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Matthew Foote', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Alexandra Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not sharing IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melanoma and Skin Cancer Trials Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}