Clinical trial NCT02068313: Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
Official title: Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 5 years
Secondary outcomes:
measure: To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Loco-regional control
timeFrame: 5 years
measure: General and specific QoL
timeFrame: 5 years
measure: Xerostomia related QoL
timeFrame: 5 years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS
role: PRINCIPAL_INVESTIGATOR
References: