Clinical trial NCT02597426: Nasopharyngeal Carcinoma Post IMRT
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Intensity-Modulated Radiotherapy
Post treatment
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of late toxicities( will be measured using CTCAE v 4.0 criteria)
timeFrame: 1 Year
measure: Serum Biochemical Tests for Endocrine Function (fT4, TSH)
timeFrame: 1 Year
measure: Quality of Life Questionnaires: Functional Assessment of Cancer Therapy (FACT-G, FACT-HN)
timeFrame: 1 Year
measure: Quality of Life Questionnaires: Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-Fatigue)
timeFrame: 1 Years
measure: Quality of Life Questionnaires: Utilities Assessment (EuroQoL - EQ-5D)
timeFrame: 1 YEAR
measure: Quality of Life Questionnaires: Symptom Burden of Treatment (MD Anderson Symptom Inventory-Head Neck)
timeFrame: 1 YEAR
measure: Quality of Life Questionnaires: Assessment of Depression and Anxiety (Hospital and Anxiety Depression Score)
timeFrame: 1 YEAR
measure: Assessment of Frontal Lobe Behavior (Frontal Systems Behaviour Scale)
timeFrame: 1 YEAR
measure: Cognitive Assessment (Montreal Cognitive Assessment - MoCA)
timeFrame: 1 YEAR
Secondary outcomes:
measure: Association of Radiation Dose with Temporal Lobe Necrosis
timeFrame: 1 Year
measure: Association of Radiation Dose with Hearing Loss
timeFrame: 1 Year
measure: Association of Radiation Dose with Cognitive Impairment
timeFrame: 1 Year
measure: Association of Radiation Dose with Pituitary Dysfunction
timeFrame: 1 Year
measure: Association of Radiation Dose with Hypothyroidism
timeFrame: 1 Year
measure: Association between dysphagia and quality of life
timeFrame: 1 Year
measure: Association between hearing and quality of life
timeFrame: 1 Year
measure: Association between hearing and quality of life
timeFrame: 1Year
measure: Association between cranial neuropathy and quality of life
timeFrame: 1Year
measure: Association between neurocognitive score (MoCA) and quality of life
timeFrame: 1 Year
measure: Association between frontal functioning and quality of life
timeFrame: 1 Year
measure: Association between pituitary function and quality of life
timeFrame: 1 Year
measure: Association between thyroid function and quality of life
timeFrame: 1 Year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: John N Waldron, MD
role: PRINCIPAL_INVESTIGATOR
References: