Nasopharyngeal CarcinomaNCT02597426
Nasopharyngeal Carcinoma Post IMRT
An observational study of Nasopharyngeal Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT)
Who may be able to join
- All patients with a previous diagnosis of NPC treated with curative intent who are alive and disease free with a minimum of four years of follow up following completion of treatment
- Received treatment with IMRT
- Age 18 or above, no upper limit
- Ability to comply with the protocol
Who cannot join
- History of recurrent nasopharyngeal disease
- A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Comprehensive Prospective Cross Sectional Study on the Late Effects of Radical Chemoradiotherapy in Nasopharyngeal Carcinoma Patients Treated in the Intensity-Modulated Radiotherapy Era
Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.
This is an observational study that is being done to learn about the long-term symptoms and side effects that survivors of nasopharyngeal cancer may have following radiation treatment. This study will include assessment of patient report outcomes, physician-graded adverse events, neurocognitive assessment and endocrine and hearing testing
Read the detailed description
This study is designed to provide comprehensive cross sectional information on the late toxicities following radical chemoradiotherapy in nasopharyngeal carcinoma in patients who are disease free with a minimum of four years follow-up and who were treated with contemporary radiotherapy techniques (IMRT). This is an observational cross-sectional study which will aim to define the late effects in this population, investigating both well known toxicities identified from studies using earlier radiotherapy techniques (2D and 3D radiotherapy) as well as toxicities which have not been well defined in the current literature and which may be under-recognized and under treated (pituitary function and neurocognitive outcomes).
This study will assess survivors at a single time point four years after completion of their treatment who are disease free. This comprehensive review will include demographic data, clinical assessment, biochemical assessment of hormonal (pituitary and thyroid) function, patient reported outcomes, and quality of life and neurocognitive questionnaires. This study will attempt to comprehensively review these toxicities in a contemporary patient group with modern radiotherapy techniques in an attempt to bridge the gap between current recommended follow up protocols and the actual challenges faced by long term survivors. Some of these factors will be correlated with radiation doses received by the patient to inform on radiation dose thresholds for appropriate toxicities (hypothalamic-pituitary, thyroid, temporal lobe necrosis, neurocognitive performance). Patients will be offered follow-up, if required with appropriate personnel if appropriate, including neuropsychology, endocrinology and otoloryngology.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Intensity-Modulated Radiotherapy, Post treatment
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT), study will involve Collection of demographic data, endocrine assessment (Pituitary and Thyroid), Patient reported outcomes (Quality of Life Questionnaire), neurocognitive assessment (Behavioral rating scale) and audiology assessment (Assessment of hearing) | |
| Caregiver/Family member | Caregivers for patients who consent to participate. Study will involve Frontal Systems Behavior Scale- FrSBe (behavioral rating scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria)
- Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death).
Measured: 1 Year
Serum Biochemical Tests for Endocrine Function (fT4, TSH)
- A single blood test (at same time as the pituitary assessment) will include free thyroxine (fT4; units pmol/L), Thyroid-Stimulating Hormone (TSH; units mIU/L),
- Biochemical serum deficiencies in morning testing will be scored individually according to CTCAEv4.03
Measured: 1 Year
Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN)
- Quality of life as measured by Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) and FACIT-Fatigue ranking individual items from 0= not at all to 4 = very much.
- An overall score is reported on the sum of individual items. The FACT-HN consists of the FACT-G (which consists of 27 questions from physical, social, emotional and functional domains) and a 12-item specific head and neck module. A maximum score for the FACT-HN of 144 reflects the best possible quality of life.
Measured: 1 Year
Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue)
A 13-item specific questionnaire scored using individual items from 0= not at all to 4 = very much collated for a total score.
Measured: 1 Years
Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D)
A standardized self-reported utility instrument consisting of 5 discrete, 3-level items, and a visual analog scale
Measured: 1 YEAR
Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck)
- A patient-reported outcome instrument consisting of 28 items, 19 related to common and severe symptoms experienced by cancer patients and 9 specific to head and neck, rated from 0=not present to 10=as bad as you can imagine
Measured: 1 YEAR
Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score)
A 14 question item scale (7 Anxiety and 7 depression) score 0-3 (each item is individually written) for individual anxiety and depressions scores from 0-21 with validated cut-off points
Measured: 1 YEAR
Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale)
A validated self-rating scale designed to measure the three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction. A 46-item questionnaire rated pre- and post treatment is scored 1=almost never to 5= almost always. Summary scores are calculated and converted to t-scores.
Measured: 1 YEAR
Cognitive Assessment (Montreal Cognitive Assessment - MoCA)
A short cognitive assessment testing several cognitive domains - visuospatial, naming, memory, attention, language, abstraction, delayed recall and orientation. A maximum score is 30.
Measured: 1 YEAR
Secondary outcomes (13)
Association of Radiation Dose with Temporal Lobe Necrosis
Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the temporal lobe and risk of temporal lobe necrosis.
Measured: 1 Year
Association of Radiation Dose with Hearing Loss
Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the cochlear and vestibulocochlear nerve and risk of hearing loss
Measured: 1 Year
Association of Radiation Dose with Cognitive Impairment
Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the temporal lobe, brain and hippocampus and risk of neurocognitive impairment.
Measured: 1 Year
Association of Radiation Dose with Pituitary Dysfunction
Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the pituitary and risk of hypopituitarism
Measured: 1 Year
Association of Radiation Dose with Hypothyroidism
Dose Volume Histograms (DVHs; quantitative radiation dose data delivered to specific organs) will be calculated from initial radiotherapy plans to review association between dose received by the thyroid gland and risk of hypothyroidism
Measured: 1 Year
Association between dysphagia and quality of life
Correlation between dysphagia and FACT-HN score and EQ-D5
Measured: 1 Year
Association between hearing and quality of life
Correlation between dysphagia and and FACT-HN score and EQ-D5
Measured: 1 Year
Association between hearing and quality of life
Correlation between degree of hearing loss (on audiology) and FACT-HN score and EQ-D5
Measured: 1Year
Association between cranial neuropathy and quality of life
Correlation between degree of cranial neuropathy and FACT-HN score and EQ-D5
Measured: 1Year
Association between neurocognitive score (MoCA) and quality of life
Correlation between Montreal Cognitive Assessment Score and FACT-HN score and EQ-D5
Measured: 1 Year
Association between frontal functioning and quality of life
Correlation between FrSBE (Frontal Systems Behaviour) and FACT-HN score and EQ-D5
Measured: 1 Year
Association between pituitary function and quality of life
Correlation between pituitary function and FACT-HN score and EQ-D5
Measured: 1 Year
Association between thyroid function and quality of life
Correlation between thyrrhoid function and FACT-HN score and EQ-D5
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John N Waldron, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597426
- Sponsor's protocol ID
- 15-9063
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2015
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Prospective Cross Sectional Study on the Late Effects of Radical Chemoradiotherapy in Nasopharyngeal Carcinoma Patients Treated in the Intensity-Modulated Radiotherapy Era
- ClinicalTrials.gov ID
- NCT02597426
- Acronym / sponsor ID
- 15-9063
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Intensity-Modulated Radiotherapy, Post treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2015 (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.
Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.
This is an observational study that is being done to learn about the long-term symptoms and side effects that survivors of nasopharyngeal cancer may have following radiation treatment. This study will include assessment of patient report outcomes, physician-graded adverse events, neurocognitive assessment and endocrine and hearing testing
Detailed description
This study is designed to provide comprehensive cross sectional information on the late toxicities following radical chemoradiotherapy in nasopharyngeal carcinoma in patients who are disease free with a minimum of four years follow-up and who were treated with contemporary radiotherapy techniques (IMRT). This is an observational cross-sectional study which will aim to define the late effects in this population, investigating both well known toxicities identified from studies using earlier radiotherapy techniques (2D and 3D radiotherapy) as well as toxicities which have not been well defined in the current literature and which may be under-recognized and under treated (pituitary function and neurocognitive outcomes).
This study will assess survivors at a single time point four years after completion of their treatment who are disease free. This comprehensive review will include demographic data, clinical assessment, biochemical assessment of hormonal (pituitary and thyroid) function, patient reported outcomes, and quality of life and neurocognitive questionnaires. This study will attempt to comprehensively review these toxicities in a contemporary patient group with modern radiotherapy techniques in an attempt to bridge the gap between current recommended follow up protocols and the actual challenges faced by long term survivors. Some of these factors will be correlated with radiation doses received by the patient to inform on radiation dose thresholds for appropriate toxicities (hypothalamic-pituitary, thyroid, temporal lobe necrosis, neurocognitive performance). Patients will be offered follow-up, if required with appropriate personnel if appropriate, including neuropsychology, endocrinology and otoloryngology.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT), study will involve Collection of demographic data, endocrine assessment (Pituitary and Thyroid), Patient reported outcomes (Quality of Life Questionnaire), neurocognitive assessment (Behavioral rating scale) and audiology assessment (Assessment of hearing) |
| Caregiver/Family member | – | –Caregivers for patients who consent to participate. Study will involve Frontal Systems Behavior Scale- FrSBe (behavioral rating scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nasopharyngeal carcinoma (NPC) patients who are disease free more than four years after definitive management with radiotherapy +/- chemotherapy who were treated with Intensity-Modulated Radiotherapy (IMRT)
Key inclusion criteria (4 listed)
- All patients with a previous diagnosis of NPC treated with curative intent who are alive and disease free with a minimum of four years of follow up following completion of treatment
- Received treatment with IMRT
- Age 18 or above, no upper limit
- Ability to comply with the protocol
Key exclusion criteria (3 listed)
- History of recurrent nasopharyngeal disease
- A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria)
Time frame: 1 Year
• Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death).
Serum Biochemical Tests for Endocrine Function (fT4, TSH)
Time frame: 1 Year
* A single blood test (at same time as the pituitary assessment) will include free thyroxine (fT4; units pmol/L), Thyroid-Stimulating Hormone (TSH; units mIU/L), * Biochemical serum deficiencies in morning testing will be scored individually according to CTCAEv4.03
Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN)
Time frame: 1 Year
* Quality of life as measured by Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) and FACIT-Fatigue ranking individual items from 0= not at all to 4 = very much. * An overall score is reported on the sum of individual items. The FACT-HN consists of the FACT-G (which consists of 27 questions from physical, social, emotional and functional domains) and a 12-item specific head and neck module. A maximum score for the FACT-HN of 144 reflects the best possible quality of life.
Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue)
Time frame: 1 Years
A 13-item specific questionnaire scored using individual items from 0= not at all to 4 = very much collated for a total score.
Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D)
Time frame: 1 YEAR
A standardized self-reported utility instrument consisting of 5 discrete, 3-level items, and a visual analog scale
Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck)
Time frame: 1 YEAR
• A patient-reported outcome instrument consisting of 28 items, 19 related to common and severe symptoms experienced by cancer patients and 9 specific to head and neck, rated from 0=not present to 10=as bad as you can imagine
Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score)
Time frame: 1 YEAR
A 14 question item scale (7 Anxiety and 7 depression) score 0-3 (each item is individually written) for individual anxiety and depressions scores from 0-21 with validated cut-off points
Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale)
Time frame: 1 YEAR
A validated self-rating scale designed to measure the three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction. A 46-item questionnaire rated pre- and post treatment is scored 1=almost never to 5= almost always. Summary scores are calculated and converted to t-scores.
Cognitive Assessment (Montreal Cognitive Assessment - MoCA)
Time frame: 1 YEAR
A short cognitive assessment testing several cognitive domains - visuospatial, naming, memory, attention, language, abstraction, delayed recall and orientation. A maximum score is 30.
13 secondary outcomes
Association of Radiation Dose with Temporal Lobe Necrosis
Time frame: 1 Year
Association of Radiation Dose with Hearing Loss
Time frame: 1 Year
Association of Radiation Dose with Cognitive Impairment
Time frame: 1 Year
Association of Radiation Dose with Pituitary Dysfunction
Time frame: 1 Year
Association of Radiation Dose with Hypothyroidism
Time frame: 1 Year
Association between dysphagia and quality of life
Time frame: 1 Year
Association between hearing and quality of life
Time frame: 1 Year
Association between hearing and quality of life
Time frame: 1Year
Association between cranial neuropathy and quality of life
Time frame: 1Year
Association between neurocognitive score (MoCA) and quality of life
Time frame: 1 Year
Association between frontal functioning and quality of life
Time frame: 1 Year
Association between pituitary function and quality of life
Time frame: 1 Year
Association between thyroid function and quality of life
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
John N Waldron, MD principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria) (time frame: 1 Year). The study lists 9 primary outcomes in all. 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 4 Mar 2026.