Head and Neck CancerNCT02068313
Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Toxicity and outcome measures of IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2010to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
The Royal Marsden Hospital
London, sw3 6jj
- Recruiting
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
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
- Conditions
- Head and Neck Cancer
- Being tested
- Toxicity and outcome measures of IMRT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxicity and outcome measures of IMRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Not described Receives: Radiation: Toxicity and outcome measures of IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (6)
To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)
Measured: 5 years
Overall survival
Measured: 5 years
Disease free survival
Measured: 5 years
Loco-regional control
Measured: 5 years
General and specific QoL
Measured: 5 years
Xerostomia related QoL
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMar 2010
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068313
- Sponsor's protocol ID
- CCR 3301
- Status last verified
- Feb 2014
- First submitted
- 19 Feb 2014
- Last updated
- 21 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT02068313
- Acronym / sponsor ID
- CCR 3301
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2017 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | Radiation: Toxicity and outcome measures of IMRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toxicity and outcome measures of IMRT | Radiation | Single cohort |
Primary outcome
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
Time frame: 5 years
6 secondary outcomes
To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia)
Time frame: 5 years
Overall survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Loco-regional control
Time frame: 5 years
General and specific QoL
Time frame: 5 years
Xerostomia related QoL
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS principal investigator
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Starkings, MSc (0207 811 8311, Rachel.Starkings@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.