Clinical Trial: Nasopharyngeal Carcinoma Post IMRT

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: A Comprehensive Prospective Cross Sectional Study on the Late Effects of Radical Chemoradiotherapy in Nasopharyngeal Carcinoma Patients Treated in the Intensity-Modulated

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 Summary:

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.


Sponsor: University Health Network, Toronto

Current 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&nbs

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Association of Radiation Dose with Temporal Lobe Necrosis [ Time Frame: 1 Year ]
      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.
    • Association of Radiation Dose with Hearing Loss [ Time Frame: 1 Year ]
      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
    • Association of Radiation Dose with Cognitive Impairment [ Time Frame: 1 Year ]
      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.
    • Association of Radiation Dose with Pituitary Dysfunction [ Time Frame: 1 Year ]
      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
    • Association of Radiation Dose with Hypothyroidism [ Time Frame: 1 Year ]
      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
    • Association between dysphagia and quality of life [ Time Frame: 1 Year ]
      Correlation between dysphagia and FACT-HN score and EQ-D5
    • Association between hearing and quality of life [ Time Frame: 1 Year ]
      Correlation between dysphagia and and FACT-HN score and EQ-D5
    • Association between hearing and quality of life [ Time Frame: 1Year ]
      Correlation between degree of hearing loss (on audiology) and FACT-HN score and EQ-D5
    • Association between cranial neuropathy and quality of life [ Time Frame: 1Year ]
      Correlation between degree of cranial neuropathy and FACT-HN score and EQ-D5
    • Association between neurocognitive score (MoCA) and quality of life [ Time Frame: 1 Year ]
      Correlation between Montreal Cognitive Assessment Score and FACT-HN score and EQ-D5
    • Association between frontal functioning and quality of life [ Time Frame: 1 Year ]
      Correlation between FrSBE (Frontal Systems Behaviour) and FACT-HN score and EQ-D5
    • Association between pituitary function and quality of life [ Time Frame: 1 Year ]
      Correlation between pituitary function and FACT-HN score and EQ-D5
    • Association between thyroid function and quality of life [ Time Frame: 1 Year ]
      Correlation between thyrrhoid function and FACT-HN score and EQ-D5


    Original Secondary Outcome: Same as current

    Information By: University Health Network, Toronto

    Dates:
    Date Received: August 18, 2015
    Date Started: June 2015
    Date Completion: June 2017
    Last Updated: October 31, 2016
    Last Verified: October 2016