HypothyroidismNCT02689609
Post-radiation Hypothyroidism After IMRT for Nasopharyngeal Carcinoma
An observational study of Hypothyroidism and Complications, run by The University of Hong Kong.
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).
- Conditions
- Hypothyroidism, Complications
- 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 group | Role | What they receive |
|---|---|---|
| Single arm | All 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.
Biochemical hypothyroidism
Time from IMRT to development of biochemical hypothyroidism
Measured: Through study completion, an average of 3 years
Secondary outcomes (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.
- First posted24 Feb 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- City University of Hong Kong
- Responsible party
- Principal investigator, Dr. Victor H.F. Lee, The University of Hong Kong
- Investigators
- Victor HF Lee, MD, Principal investigator, The University of Hong Kong
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Predictors of Hypothyroidism After Radical Intensity-modulated Radiation Therapy for Non-metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02689609
- Acronym / sponsor ID
- Version 1.0
- Conditions
- Hypothyroidism, Complications
- Keywords
- Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Hypothyroidism, Predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- City University of Hong Kong
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Radiation: Intensity-modulated radiation therapyAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients with previously untreated non-metastatic NPC who are planned to receive radical intensity-modulated radiation therapy with or without adjunct chemotherapy.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiation therapyAll patients will receive intensity-modulated radiation therapy with or without chemotherapy as usual standard of care in our institution. | Radiation | Single arm |
Primary outcome
Biochemical hypothyroidism
Time frame: Through study completion, an average of 3 years
Time from IMRT to development of biochemical hypothyroidism
1 secondary outcome
Clinical hypothyroidism
Time frame: Through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor HF Lee, MD principal investigator
The University of Hong Kong
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.