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Neurotropic Melanoma of the Head and Neck

2014-08-27 03:19:24 | BioPortfolio

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).

Study Design

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

Conditions

Neurotropic Melanoma of the Head and Neck

Intervention

Observation, Radiation Therapy

Location

Royal Prince Alfred Hospital
Camperdown
New South Wales
Australia
2050

Status

Recruiting

Source

Trans-Tasman Radiation Oncology Group (TROG)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:24-0400

Clinical Trials [4706 Associated Clinical Trials listed on BioPortfolio]

Radiation Therapy in Treating Patients With Head and Neck Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer. PURPOSE: Ran...

Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.

This is a Phase 2, single center study to evaluate the efficacy, safety of nivolumab in combination with radiation therapy in patients with mucosal melanoma of the head and neck (MMHN). Ta...

Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer

The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and ...

Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and...

Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patient...

PubMed Articles [15208 Associated PubMed Articles listed on BioPortfolio]

Expression of CD44, EGFR, p16, and their mutual combinations in patients with head and neck cancer: Impact on outcomes of intensity-modulated radiation therapy.

Progress in radiation treatment of head and neck squamous cell carcinoma (HNSCC) deserves the studies focused on molecular predictors that would help to enhance individually tailored treatment.

Intensity-modulated radiation therapy (IMRT) versus 3-dimensional conformal radiation therapy (3D-CRT) for head and neck cancer: cost-effectiveness analysis.

A cost-effectiveness analysis of IMRT compared to 3D-CRT for head and neck cancer patients (HNCPs) was conducted in the Brazilian Public Health System.

A Quantitative Clinical Decision-support Strategy Identifying Which Oropharyngeal Head and Neck Cancer Patients may Benefit the Most from Proton Radiation Therapy.

Developing a quantitative decision-support strategy estimating the impact of normal tissue complications from definitive radiation therapy (RT) for head and neck cancer (HNC). We developed this strate...

Locoregional Control and Toxicity in Head and Neck Carcinoma Patients following Helical Tomotherapy-Delivered Intensity-Modulated Radiation Therapy Compared with 3D-CRT Data.

To assess the feasibility and efficacy of intensity-modulated radiation implemented with helical tomotherapy image-guided with daily megavoltage computed tomography for head and neck cancer.

Optimal resection margin for head and neck cutaneous melanoma.

The objective of this study was to examine the difference between a narrow (between 1 and 2 cm) and a wide (>2 cm) margin in the surgical resection of head and neck cutaneous melanoma.

Medical and Biotech [MESH] Definitions

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

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