NCT02597426

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

Active, enrolled Last updated 3 March 2026

What this trial tests

trial in Nasopharyngeal Carcinoma in 108 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2015

Primary endpoint
1 December 2027

1 December 2027

Quick facts

Lead sponsor	University Health Network, Toronto
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	108
Start date	1 June 2015
Primary completion	1 December 2027
Estimated completion	1 December 2027
Sites	1 location across Canada

Conditions studied

• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Nasopharyngeal Carcinoma. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.