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Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and neck cancers treated with radiotherapy. This study will be an extension to an earlier, in-house, trial to allow continued recording of toxicities and outcomes in patients receiving IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling for normal tissue complication probability and in particular, determining the dose threshold for parotid glands. Our primary objective is to assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toxicity and outcome measures of IMRT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia) | 5 years | |
| Overall survival | 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary referred for primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Starkings, MSc | Contact | 0207 811 8311 | Rachel.Starkings@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden Hospital | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom | |
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| Disease free survival |
| 5 years |
| Loco-regional control | 5 years |
| General and specific QoL | 5 years |
| Xerostomia related QoL | 5 years |
| The Royal Marsden Hospital |
| Recruiting |
| London |
| sw3 6jj |
| United Kingdom |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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