Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Toxicity and outcome measures of IMRT

• Registration Number: NCT02068313
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Status Verified: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-21
• Last Update Posted: 2014-02-21
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary.
• TNM Stage: T1-4, N0-3 M0
• Patients requiring primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT
• Parotid sparing IMRT feasible (parotids clear of malignant disease)
• WHO Performance status 0-1 (Karnofsky >80)
• Aged 18 or older
• Induction chemotherapy and concomitant platinum based chemotherapy is permitted
• Concomitant cetuximab is permitted where platinum chemotherapy is contraindicated
• All patients must be suitable to attend regular follow-up and salivary flow measurements and be available for long term follow up.
• All patients must be able to complete self-assessed quality of life questionnaire
• Be able to provide written informed consent

Exclusion Criteria

• Previous radiotherapy to the parotid gland/s
• Pre-existing salivary gland pathology interfering with saliva production
• Previous or concurrent illness which in the investigator's opinion which will interfere with either completion of therapy or follow up
• Brachytherapy is not allowed as part of the treatment
• Presence of lymphadenopathy adjacent to or involving both parotid glands making whole parotid sparing or superficial parotid sparing impossible
• Prophylactic use of amifostine or pilocarpine is not allowed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single cohort	Toxicity and outcome measures of IMRT	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
Disease free survival	5 years
Loco-regional control	5 years
General and specific QoL	5 years
Xerostomia related QoL	5 years

Trial Locations

Locations (1)

The Royal Marsden Hospital; 🇬🇧 London, United Kingdom