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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02068313
• Other study ID #: CCR 3301
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2014
• Last updated: February 19, 2014
• Start date: March 2010

Study information

• Verified date: February 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: Rachel Starkings, MSc
• Phone: 0207 811 8311
• Email: Rachel.Starkings[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Health Research Authority - National Research Ethics Service
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Toxicity and outcome measures of IMRT

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital	London
United Kingdom	The Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)		5 years	No
Secondary	Overall survival		5 years	No
Secondary	Disease free survival		5 years	No
Secondary	Loco-regional control		5 years	No
Secondary	General and specific QoL		5 years	No
Secondary	Xerostomia related QoL		5 years	No