Neurotropic Melanoma of the Head and Neck (RTN2)
This study is currently recruiting participants.
Verified December 2009 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Collaborator:
Australia and New Zealand Melanoma Trials Group
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00975520
First received: September 10, 2009
Last updated: December 1, 2009
Last verified: December 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Neurotropic Melanoma of the Head and Neck |
Other: Observation Radiation: Radiation Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck |
Resource links provided by NLM:
Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary Outcome Measures:
- Time to local relapse [ Time Frame: 5 years from the date of randomisation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Relapse free survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
- Time to Relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
- Cancer specific survival [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
- Patterns of relapse [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: No ]
- Late Toxicity [ Time Frame: 5 years from date of randomisation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Radiation Therapy
Investigational Treatment
|
Radiation: Radiation Therapy
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.
Other Name: RT, radiotherapy
|
|
No Intervention: Initial Observation
Initial Observation
|
Other: Observation
Patients will be observed after surgery until recurrence when they will be offered radiation therapy
Other Name: Surgery Alone
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged 18 years or older
- Has provided written informed consent for participation in this trial
- Histologically confirmed neurotropic primary melanoma
- Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)
- Complete macroscopic resection of all known disease with or without microscopic positive margins
- No previous surgery for melanoma (other than complete macroscopic resection as stated above)
- No evidence of in-transit, nodal or distant metastases as determined by clinical examination, CT or MRI
- ECOG performance status score of 2 or less
- Life expectancy greater than 6 months
- Patients capable of childbearing are using adequate contraception
- Available for follow up
Exclusion Criteria:
- Women who are pregnant or lactating
- Intercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical condition
- Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour
- Inability to localise surgical bed on CT scans and/or surgical margins (cm) not known
- 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
- High risk for poor compliance with therapy or follow-up as assessed by investigator
- 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
- Albinism
- Participation in other clinical trials with the same primary endpoint
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975520
Contacts
| Contact: Prof. Bryan Burmeister | +61 07 3240 6581 | Bryan_Burmeister@health.qld.gov.au |
| Contact: Janelle Meakin | +61 07 3240 2498 ext 2498 | Janelle_Meakin@health.qld.gov.au |
Locations
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | Not yet recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: Janelle Meakin +61 07 3240 2498 ext 2498 Janelle_meakin@health.qld.gov.au | |
| Principal Investigator: Prof. Bryan Burmeister | |
| Australia, South Australia | |
| Royal Adelaide Hospital | Not yet recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Institute | Not yet recruiting |
| Melbourne, Victoria, Australia, 3002 | |
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australia and New Zealand Melanoma Trials Group
Investigators
| Study Chair: | Bryan Burmeister | Trans-Tasman Radiation Oncology Group (TROG) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Trans Tasman Radiation Oncology Group (TROG) |
| ClinicalTrials.gov Identifier: | NCT00975520 History of Changes |
| Other Study ID Numbers: | TROG 08.09, 2009/039 |
| Study First Received: | September 10, 2009 |
| Last Updated: | December 1, 2009 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
|
Neurotropic Melanoma Observation Radiation Therapy Relapse |
Additional relevant MeSH terms:
|
Melanoma 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 19, 2013