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

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

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Toxicity and outcome measures of IMRT

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Rachel Starkings, MSc; Phone Number: 0207 811 8311; Email: Rachel.Starkings@rmh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • The Royal Marsden Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • The Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single cohort	Radiation: Toxicity and outcome measures of IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Disease free survival	5 years
Loco-regional control	5 years
To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)	5 years
General and specific QoL	5 years
Xerostomia related QoL	5 years

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CCR 3301