NCT02068313

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

7.3 years

First QC Date

February 19, 2014

Last Update Submit

February 19, 2014

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Single cohort

Radiation: Toxicity and outcome measures of IMRT

Interventions

Toxicity and outcome measures of IMRTRADIATION
Single cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

The Royal Marsden Hospital

London, sw3 6jj, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Starkings, MSc

CONTACT

0207 811 8311Rachel.Starkings@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

March 1, 2010

Primary Completion

July 1, 2017

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

GB(2)