Trial · NCT01882816
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
NCT01882816, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2022-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer. Trials, record NCT01882816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01882816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
- NCT number
- NCT01882816
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Thyroid Cancer
- Interventions
- IMRT, DWI MRI, Doxorubicin, Modified Barium Swallow Impairment Profile (MBSImP)
- First posted
- 2013-06-20
- Last updated
- 2022-12-29
- Results first posted
- 2022-12-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Local-regional Progression-free Survival | 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. |
| Secondary | Overall Survival | 2 years | |
| Secondary | Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 2 years | 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. |
| Secondary | Rate of Late Dysphagia | 2 years | 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 |
| Secondary | Rate of Late Xerostomia/Dry Mouth | 2 years | 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 |
| Secondary | Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | 12 months | Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Local-regional Progression-free Survival | 2 years | percentage of all participants | NUMBER | |
| SECONDARY | Overall Survival | 2 years | percentage of participants alive | NUMBER | |
| SECONDARY | Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Rate of Late Dysphagia | 2 years | percent of pts experiencing dysphagia | NUMBER | |
| SECONDARY | Rate of Late Xerostomia/Dry Mouth | 2 years | percent of pts experiencing dry mouth | NUMBER | |
| SECONDARY | Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Local-regional Progression-free Survival | IMRT and Doxorubicin | 15.2 | percentage of all participants | ||
| Overall Survival | IMRT and Doxorubicin | 77.3 | 95% Confidence Interval 62.8 to 95.1 | percentage of participants alive | |
| Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | IMRT and Doxorubicin | 33.4 | percentage of participants | ||
| Rate of Late Dysphagia | IMRT and Doxorubicin | 8.0 | percent of pts experiencing dysphagia | ||
| Rate of Late Xerostomia/Dry Mouth | IMRT and Doxorubicin | 4.0 | percent of pts experiencing dry mouth | ||
| Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | IMRT and Doxorubicin | Participants with significant functional difference as compared to baseline | 0 | Participants | |
| Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | IMRT and Doxorubicin | Participants without significant functional difference as compared to baseline | 27 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMRT and Doxorubicin | 27 | |
| Overall Study | COMPLETED | IMRT and Doxorubicin | 27 | |
| Overall Study | NOT COMPLETED | IMRT and Doxorubicin | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | IMRT and Doxorubicin | 4 | 27 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | IMRT and Doxorubicin | 4 | 27 | |
| other | Hypocalcemia | Metabolism and nutrition disorders | IMRT and Doxorubicin | 3 | 27 | |
| other | Lymphocyte count decreased | Investigations | IMRT and Doxorubicin | 22 | 27 | |
| other | Neutrophil count decreased | Investigations | IMRT and Doxorubicin | 4 | 27 | |
| other | Platelet count decreased | Investigations | IMRT and Doxorubicin | 3 | 27 | |
| other | White blood cell decreased | Investigations | IMRT and Doxorubicin | 4 | 27 | |
| serious | Stoma site infection | Infections and infestations | IMRT and Doxorubicin | 1 | 27 | |
| serious | Stridor | Respiratory, thoracic and mediastinal disorders | IMRT and Doxorubicin | 3 | 27 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMRT and Doxorubicin | 11 | 27 |
| Total, other adverse events | IMRT and Doxorubicin | 22 | 27 |
| Total, serious adverse events | IMRT and Doxorubicin | 3 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34293201 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01882816
GET https://conductscience.org/api/trials/v1/NCT01882816/registered