Nasopharyngeal Carcinoma Post IMRT

NCT ID: NCT02597426

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2027-12-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

No interventions assigned to this group

Caregiver/Family member

Caregivers for patients who consent to participate. Study will involve Frontal Systems Behavior Scale- FrSBe (behavioral rating scale)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John N Waldron, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 15-9063-CE

Identifier Type: -

Identifier Source: org_study_id