Thyroid CancerPhase 2NCT01882816
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
A Phase 2 study testing IMRT, DWI MRI and Doxorubicin in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- IMRT, DWI MRI and Doxorubicin
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Jun 2013to 4 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
- Age ≥18 years
- Karnofsky performance status ≥70%
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Women who are pregnant or lactating
- Inability to comply with study and/or follow-up procedures
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
About this study
Official title: A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.
- Conditions
- Thyroid Cancer
- Being tested
- IMRT, DWI MRI, Doxorubicin, Modified Barium Swallow Impairment Profile (MBSImP)
- Keywords
- non-anaplastic, non-medullary, radiation, IMRT, Doxorubicin, 13-070
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC
DWI MRIDevice
The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.
DoxorubicinDrug
Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
Modified Barium Swallow Impairment Profile (MBSImP)Other
The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
| Study group | Role | What they receive |
|---|---|---|
| IMRT and doxorubicin | Experimental | All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. Receives: Radiation: IMRT; Device: DWI MRI; Drug: Doxorubicin; Other: Modified Barium Swallow Impairment Profile (MBSImP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Local-regional Progression-free Survival
2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis.
Measured: 2 years
Secondary outcomes (5)
Overall Survival
Measured: 2 years
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities
During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 Physician-reported acute grade 3 or higher treatment-related toxicities, regardless of attribution.
Measured: 2 years
Rate of Late Dysphagia
Grade 2 or higher late toxicity rate. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0
Measured: 2 years
Rate of Late Xerostomia/Dry Mouth
Rate of late xerostomia/dry mouth. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0
Measured: 2 years
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline
Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study start13 Jun 2013
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882816
- Sponsor's protocol ID
- 13-070
- Status last verified
- Nov 2021
- First submitted
- 13 Jun 2013
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Romesser PB, Sherman EJ, Whiting K, Ho ML, Shaha AR, Sabra MM, Riaz N, Waldenberg TE, Sabol CR, Ganly I, McBride SM, Fagin JA, Zhang Z, Tuttle RM, Wong RJ, Lee NY. Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial. Cancer. 2021 Nov 15;127(22):4161-4170. doi: 10.1002/cncr.33804. Epub 2021 Jul 22.
PubMed 34293201
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01882816
- Acronym / sponsor ID
- 13-070
- Conditions
- Thyroid Cancer
- Keywords
- non-anaplastic, non-medullary, radiation, IMRT, Doxorubicin, 13-070
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Jun 2013 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Posted 29 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT and doxorubicin | Experimental | Radiation: IMRT, Device: DWI MRI, Drug: Doxorubicin, Other: Modified Barium Swallow Impairment Profile (MBSImP)All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
- Age ≥18 years
- Karnofsky performance status ≥70%
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
- Patients must have ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- Women who are pregnant or lactating
- Inability to comply with study and/or follow-up procedures
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 |
|---|---|---|
| IMRTPatients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC | Radiation | IMRT and doxorubicin |
| DWI MRIThe DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated. | Device | IMRT and doxorubicin |
| DoxorubicinLow dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. | Drug | IMRT and doxorubicin |
| Modified Barium Swallow Impairment Profile (MBSImP)The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments. | Other | IMRT and doxorubicin |
Primary outcome
Percentage of Participants With Local-regional Progression-free Survival
Time frame: 2 years
2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis.
5 secondary outcomes
Overall Survival
Time frame: 2 years
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities
Time frame: 2 years
Rate of Late Dysphagia
Time frame: 2 years
Rate of Late Xerostomia/Dry Mouth
Time frame: 2 years
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34293201Romesser PB, Sherman EJ, Whiting K, Ho ML, Shaha AR, Sabra MM, Riaz N, Waldenberg TE, Sabol CR, Ganly I, McBride SM, Fagin JA, Zhang Z, Tuttle RM, Wong RJ, Lee NY. Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial. Cancer. 2021 Nov 15;127(22):4161-4170. doi: 10.1002/cncr.33804. Epub 2021 Jul 22.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT, DWI MRI and Doxorubicin in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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 5 inclusion and 2 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 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Local-regional Progression-free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882816, which also lists 1 linked publication.
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 29 Dec 2022.