Head and Neck CancerNCT02112344
A Study of Intensity-modulated Radiotherapy in Patients With Squamous Cell Carcinoma of Unknown Primary (SCCUP) of the Head and Neck
A study testing IMRT in people with Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust.
Trial summary
Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes at presentation is a relatively rare entity forming about 2% of all head and neck carcinomas. 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?
- IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- Squamous cell carcinomas metastatic to cervical lymph node with occult primary requiring bilateral neck and pan mucosal irradiation.
- Radiotherapy either as primary therapy or post-operative (adjuvant irradiation).
- Neoadjuvant and concomitant chemotherapy are permitted.
- All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
- Stage T0, N1-3, M0 disease
- WHO Performance Status 0-1.
- Patient should have a negative PET/CT scan for a primary tumour.
Who cannot join
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
- Prophylactic use of amifostine or pilocarpine is not allowed
- Brachytherapy is not allowed as part of the treatment
About this study
Official title: A Phase I Study of Intensity-modulated Radiotherapy in Patients With Squamous Cell Carcinoma of Unknown Primary (SCCUP) of the Head and Neck
Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes at presentation is a relatively rare entity forming about 2% of all head and neck carcinomas.
Typically patients are treated with ipsilateral modified radical neck dissection (MRND) and post-operative radiotherapy (PORT) or chemoradiotherapy.
Read more
There is a lack of consensus on the radiotherapy target volumes that should be treated after neck dissection. The most common radiotherapy techniques are either unilateral cervical lymph node irradiation to achieve local control in the ipsilateral neck or TMI of the head and neck region with the aim of eradicating the primary and the microscopic neck disease.
Treatment of the ipsilateral hemi-neck alone is of low toxicity and may achieve local control in the cervical nodes. Potential occult primary sites in the head and neck mucosa, and any sub-clinical metastatic disease in the contralateral side of the neck are left untreated. If a primary tumour subsequently becomes apparent the previous radiotherapy may make further radiotherapy difficult to deliver.
Some groups recommend bilateral neck and total mucosal irradiation in this setting claiming improved local control. With conventional radiotherapy technique this is at the price of significant acute toxicity and chronic morbidity, mainly xerostomia with its associated complications and effects on quality of life (QOL).
Intensity modulated radiotherapy (IMRT) has been shown to reduce the dose to salivary gland tissue and consequently may reduce the incidence of xerostomia and improve quality of life (QOL) in head and neck cancer patients.
An analysis of parotid-sparing IMRT at the University of Michigan established a mean dose threshold for both stimulated (26 Gy), and unstimulated (24 Gy) saliva flow rates. For the same end-point (less than 25% of flow at baseline one year post radiation) Roesink et al established a TD50 of 39 Gy.
The investigators performed a planning study to assess the feasibility of IMRT to spare the parotid gland while delivering bilateral neck and TMI. The mean dose to the contralateral parotid gland using IMRT was below the threshold of 24 Gy for unstimulated salivary flow, predicting a fairly low risk of radiation induced xerostomia. The mean dose to the ipsilateral parotid gland was 32 Gy which was below the TD50 dose based on the Roesink data.
This study assesses the safety and tolerability of delivering IMRT in clinical practice to treat patients with SCCUP of the head and neck region, who require bilateral neck and pan-mucosal irradiation.
- Conditions
- Head and Neck Cancer
- Being tested
- 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.
IMRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Total mucosal irradiation | Experimental | Not described Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delivering IMRT
Feasibility of delivering IMRT in this setting i.e. all the patients completing the radiotherapy protocol without treatment breaks due to toxicity.
Measured: 7 weeks after starting radiotherapy
Secondary outcomes (15)
Incidence of acute dermatitis
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of >grade 1 late xerostomia
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years
Number of patients who do not relapse at the local site
Local control assessed at 3, 6 months, then every 6 months to 5 years.
Measured: 5 years
Overall survival
Assessed at 3 and 6 months then every 6 months to 5 years.
Measured: 5 years
Incidence of acute alopecia
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of >grade 1 acute dysphagia
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of > grade 1 acute mucositis
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of acute radiation induced pain
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of >grade 1 acute xerostomia
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of acute radiation induced fatigue
Outcome measured at baseline, weeks 1-6 during RT. Weeks 1-4 and 8 after RT.
Measured: 3 months after RT
Incidence of > grade 1 late dysphagia
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years after RT
Incidence of late oesophageal stricture
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years after RT
Incidence of >grade 1 late hoarse voice
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years after RT
Incidence of late radiation induced neurological dysfunction
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years
Incidence of >grade1 late skin toxicity
Outcome measured at 3, 6, 12, 18, 24 months after RT.
Measured: 5 years after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJul 2007
- Primary completionSep 2010
- Study completionOct 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher M Nutting, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112344
- Sponsor's protocol ID
- CCR 2823
- Status last verified
- Sep 2020
- First submitted
- 13 Mar 2014
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intensity-modulated Radiotherapy in Patients With Squamous Cell Carcinoma of Unknown Primary (SCCUP) of the Head and Neck
- ClinicalTrials.gov ID
- NCT02112344
- Acronym / sponsor ID
- CCR 2823
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Apr 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.
Squamous cell carcinoma of unknown primary (SCCUP) site metastatic to cervical lymph nodes at presentation is a relatively rare entity forming about 2% of all head and neck carcinomas.
Typically patients are treated with ipsilateral modified radical neck dissection (MRND) and post-operative radiotherapy (PORT) or chemoradiotherapy.
There is a lack of consensus on the radiotherapy target volumes that should be treated after neck dissection. The most common radiotherapy techniques are either unilateral cervical lymph node irradiation to achieve local control in the ipsilateral neck or TMI of the head and neck region with the aim of eradicating the primary and the microscopic neck disease.
Treatment of the ipsilateral hemi-neck alone is of low toxicity and may achieve local control in the cervical nodes. Potential occult primary sites in the head and neck mucosa, and any sub-clinical metastatic disease in the contralateral side of the neck are left untreated. If a primary tumour subsequently becomes apparent the previous radiotherapy may make further radiotherapy difficult to deliver.
Some groups recommend bilateral neck and total mucosal irradiation in this setting claiming improved local control. With conventional radiotherapy technique this is at the price of significant acute toxicity and chronic morbidity, mainly xerostomia with its associated complications and effects on quality of life (QOL).
Intensity modulated radiotherapy (IMRT) has been shown to reduce the dose to salivary gland tissue and consequently may reduce the incidence of xerostomia and improve quality of life (QOL) in head and neck cancer patients.
An analysis of parotid-sparing IMRT at the University of Michigan established a mean dose threshold for both stimulated (26 Gy), and unstimulated (24 Gy) saliva flow rates. For the same end-point (less than 25% of flow at baseline one year post radiation) Roesink et al established a TD50 of 39 Gy.
The investigators performed a planning study to assess the feasibility of IMRT to spare the parotid gland while delivering bilateral neck and TMI. The mean dose to the contralateral parotid gland using IMRT was below the threshold of 24 Gy for unstimulated salivary flow, predicting a fairly low risk of radiation induced xerostomia. The mean dose to the ipsilateral parotid gland was 32 Gy which was below the TD50 dose based on the Roesink data.
This study assesses the safety and tolerability of delivering IMRT in clinical practice to treat patients with SCCUP of the head and neck region, who require bilateral neck and pan-mucosal irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total mucosal irradiation | Experimental | Radiation: IMRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Squamous cell carcinomas metastatic to cervical lymph node with occult primary requiring bilateral neck and pan mucosal irradiation.
- Radiotherapy either as primary therapy or post-operative (adjuvant irradiation).
- Neoadjuvant and concomitant chemotherapy are permitted.
- All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
- Stage T0, N1-3, M0 disease
Key exclusion criteria (5 listed)
- Previous radiotherapy to the head and neck region
- Previous malignancy except non-melanoma skin cancer
- Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
- Prophylactic use of amifostine or pilocarpine is not allowed
- Brachytherapy is not allowed as part of the treatment
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 |
|---|---|---|
| IMRT | Radiation | Total mucosal irradiation |
Primary outcome
Feasibility of delivering IMRT
Time frame: 7 weeks after starting radiotherapy
Feasibility of delivering IMRT in this setting i.e. all the patients completing the radiotherapy protocol without treatment breaks due to toxicity.
15 secondary outcomes
Incidence of acute dermatitis
Time frame: 3 months after RT
Incidence of >grade 1 late xerostomia
Time frame: 5 years
Number of patients who do not relapse at the local site
Time frame: 5 years
Overall survival
Time frame: 5 years
Incidence of acute alopecia
Time frame: 3 months after RT
Incidence of >grade 1 acute dysphagia
Time frame: 3 months after RT
Incidence of > grade 1 acute mucositis
Time frame: 3 months after RT
Incidence of acute radiation induced pain
Time frame: 3 months after RT
Incidence of >grade 1 acute xerostomia
Time frame: 3 months after RT
Incidence of acute radiation induced fatigue
Time frame: 3 months after RT
Incidence of > grade 1 late dysphagia
Time frame: 5 years after RT
Incidence of late oesophageal stricture
Time frame: 5 years after RT
Incidence of >grade 1 late hoarse voice
Time frame: 5 years after RT
Incidence of late radiation induced neurological dysfunction
Time frame: 5 years
Incidence of >grade1 late skin toxicity
Time frame: 5 years after RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
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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 M Nutting, PhD principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing IMRT in people with Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering IMRT (time frame: 7 weeks after starting radiotherapy). 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 7 Sep 2020.