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HypothyroidismNCT02689609

Post-radiation Hypothyroidism After IMRT for Nasopharyngeal Carcinoma

An observational study of Hypothyroidism and Complications, run by The University of Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators evaluate if there are radiation dosimetric parameters for the prediction of biochemical and clinical hypothyroidism after intensity-modulated radiation therapy (IMRT) for non-metastatic nasopharyngeal carcinoma (NPC). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypothyroidism, Complications
What is being tested?
Intensity-modulated radiation therapy
Type of treatment
Surgery or procedure
How many people
149 participants
Where
No sites listed yet
Study dates
Jan 2008to Dec 2016
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Eligible patients included those with previously untreated non-metastatic nasopharyngeal carcinoma (NPC) who received only one course of radical IMRT with or without adjunct chemotherapy for their NPC as curative treatment.

Who may be able to join

  • Patients with previously untreated non-metastatic NPC who are planned to receive radical intensity-modulated radiation therapy with or without adjunct chemotherapy.

Who cannot join

  • Patients who are not able to give written informed consent
  • Patients who are pregnant or lactating at the time of written consent
  • Patients who have significant cardiovascular, cerebrovascular and psychiatric illness as judged serious by investigators.

About this study

Official title: Dosimetric Predictors of Hypothyroidism After Radical Intensity-modulated Radiation Therapy for Non-metastatic Nasopharyngeal Carcinoma

The investigators evaluate if there are radiation dosimetric parameters for the prediction of biochemical and clinical hypothyroidism after intensity-modulated radiation therapy (IMRT) for non-metastatic nasopharyngeal carcinoma (NPC).

Read the detailed description

Eligible patients include those with previously untreated non-metastatic nasopharyngeal carcinoma (NPC) who will receive only one course of radical IMRT with or without adjunct chemotherapy for their NPC as curative treatment. Patients who have a history of any thyroid disorders, pituitary disorders, prior thyroid surgery or a drug history of thyroxine (T4) or triiodothyronine (T3) are excluded. Patients who have a history of radiation therapy to other areas are also excluded. Pretreatment investigations and workup include serum hematology, biochemistry, antibodies against Epstein-Barr virus (EBV) viral capsid antigen (VCA) and early antigen (EA), fabrication of customized head and neck thermoplastic cast for subsequent contrast-enhanced computed tomography (CT) scan of the head and neck region down to mid-thoracic region in IMRT treatment position with 3mm thickness, as well as T1-sequence, T2-sequence and gadolinium-enhanced magnetic resonance imaging (MRI) of the head and neck region by a 3-tesla scanner with the images co-registered with the planning head and neck CT images for detailed target and organ-at-risk (OAR) delineation and IMRT planning. A separate contrast-enhanced CT scan of the thorax and abdomen will also be performed to rule out distant metastasis.

The gross tumour volumes of both the primary tumour (GTV-P) and the radiologically involved cervical nodes (GTV-N) are outlined on the planning CT images with the aid of co-registered MRI images. Subsequently clinical target volume (CTV-70) and planning target volume containing CTV-70 with a 3mm margin (PTV-70) are generated to take into account the microscopic disease spread, physiological body motions and set-up errors respectively. Another CTV-66 encompassing the high risk areas including the posterior half of the maxillary sinuses, nasal cavities, parapharyngeal spaces, styloid processes, basi-occiput, basi-sphenoid, clivus, foramina rotunda and ovale, pterygopalatine fossae, pterygomaxillary fissures, infra-orbital fissures, cavernous sinuses and level Ib and level V nodal stations is also contoured. A corresponding PTV-66 with a 3mm margin encompassing CTV-66 is created by boolean operations of the treatment planning system which is also used for IMRT optimization and planning. All OARs including brainstem, spinal cord, globes, optic nerves, optic chiasm, lenses, temporomandibular joints, temporal lobes, auditory nerves, cochleae, mandible, oral cavity, larynx, parotid glands, vestibules, pituitary and thyroid are to be contoured manually. During IMRT optimization, the maximum dose of brainstem, optic nerves and chiasm must be <=54 Gy (allowing 0.1cc brainstem <60 Gy) and spinal cord <=45 Gy (allowing 0.1cc spinal cord <48 Gy). Efforts will also made to limit mean dose of parotid glands to 26 Gy whenever possible and dose to the lenses and temporal lobes as low as reasonably achieved without compromising dose coverage to the PTVs. No dose constraint is to be given to the thyroid and pituitary during optimization of all IMRT plans.

A 7 to 9 field IMRT plan delivered by step-and-shoot technique with a 6-megavoltage linear accelerator will be generated by Eclipse Treatment Planning System. A total dose of 70 Gy and 66 Gy was prescribed to PTV-70 and PTV-66 respectively, all in 33 to 35 fractions over 6.5 to 7 weeks by simultaneous accelerated radiation therapy technique (SMART). The whole neck was irradiated with IMRT and no matching anterior field to the lower neck was noted. This has been the standard prescription and practice in our institution for the past 10 years. Positional verification with on-board imaging was performed before IMRT commencement. It was repeated again daily immediately before the first 3 fractions of IMRT and then weekly afterwards during the whole course of IMRT, to track any anteroposterior and lateral body displacements.

All patients had routine 6-site nasopharyngeal biopsies at 8 weeks after IMRT to confirm local clinical remission. Repeated nasopharyngeal biopsies were performed at 10 weeks and 12 weeks after IMRT if residual tumour cells were still observed in previous post-IMRT nasopharyngeal biopsies. Additional radiation therapy in the form of intracavitary brachytherapy, stereotactic radiation therapy or IMRT would be given if patients developed local persistence at 12 weeks after IMRT. For patients confirmed to be local clinical remission, they received regular clinical follow up and imaging surveillance every 3 to 4 months for the 1st year after IMRT, then every 4 to 6 months for the 2nd and 3rd year and yearly afterwards to monitor for any treatment-related chronic complications and relapse. Blood tests for thyroid function tests including free T4 and thyroid stimulating hormone (TSH) will be arranged at least once yearly to monitor post-IMRT hypothyroidism. Biochemical hypothyroidism is defined as either elevation of TSH above the upper normal limit or reduced free T4 below the lower normal limit or both, without the presence of clinical symptoms of hypothyroidism. Clinical hypothyroidism is defined as the presence of biochemical abnormalities of thyroid function same as that defined for biochemical hypothyroidism together with the presence of clinical symptoms of hypothyroidism. Those who are found to have clinical hypothyroidism will receive thyroxine supplement starting with 50 micrograms daily with repeated serum thyroid function tests 2 to 3 months later followed by dose titration if necessary, then every 6 to 12 months thereafter when therapeutic dosage was reached.

Univariable and multivariable binary logistic regression will be performed for dosimetric predictors of biochemical and clinical hypothyroidism. All statistical analyses will be performed by Statistical Package for Social Sciences (SPSS) and statistical significance is defined as p-value <0.05 (two-sided).

Being tested
Intensity-modulated radiation therapy
Keywords
Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Hypothyroidism, Predictors
Medical subject headings
Hypothyroidism, Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity-modulated radiation therapyRadiation

    All patients will receive intensity-modulated radiation therapy with or without chemotherapy as usual standard of care in our institution.

Study groups in NCT02689609
Study groupRoleWhat they receive
Single armAll patients will receive intensity-modulated radiation therapy (IMRT) with or without adjunct chemotherapy as standard of care. They will have baseline pre-treatment and post-IMRT serum thyroid function test at least yearly after IMRT.
Receives: Radiation: Intensity-modulated radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical hypothyroidism

    Time from IMRT to development of biochemical hypothyroidism

    Measured: Through study completion, an average of 3 years

Secondary outcomes (1)
  1. Clinical hypothyroidism

    Time from IMRT to development of clinical hypothyroidism

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2016 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2013
  4. Study completionDec 2016

Resources

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
Prospective
Enrolment
149 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689609
Sponsor's protocol ID
Version 1.0
Status last verified
Sep 2019
First submitted
15 Feb 2016
Last updated
2 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No: There is no plan to make individual participant data available.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypothyroidism and Complications, run by The University of Hong Kong.

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 1 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: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Biochemical hypothyroidism (time frame: Through study completion, an average of 3 years). 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 2 Oct 2019.

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