Trial · NCT04759911
Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
NCT04759911, Phase 2, Active not recruiting, M.D. Anderson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer. Trials, record NCT04759911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04759911
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
- NCT number
- NCT04759911
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Malignant Thyroid Gland Neoplasm, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Carcinoma, Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Medullary Carcinoma, Thyroid Gland Papillary Carcinoma, Thyroid Gland Squamous Cell Carcinoma
- Interventions
- Quality-of-Life Assessment, Questionnaire Administration, Selpercatinib, Therapeutic Conventional Surgery
- First posted
- 2021-02-18
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | Up to 7 months | Defined as the percentage of number of complete response or partial response in total number of patients treated. With ORR by Response Evaluation Criteria in Solid Tumors (RECIST), will report the percentages of patients that fall into each of the four categories: complete response, partial response, stable disease or progressive disease according to RECIST 1.1. |
| Primary | Tumor response | Up to 7 months | Assessed using modified neck RECIST, which applies the RECIST criteria only to lesions above the clavicles. Will report the percentages of patients that fall into each of the four categories: complete response, partial response, stable disease or progressive disease according to modified neck RECIST 1.1. |
| Secondary | R0/R1 resection rates | During surgery | Defined by proportion of patients who undergo successful thyroidectomy with clear (R0) or microscopically positive (R1) surgical margins. Will evaluate R0/R1 resection rates in each of 4 pre-specified extrathyroidal anatomic target interfaces: 1) perithyroid muscles (e.g. strap, sternocleidomastoid, inferior constrictor muscles) 2) cartilage (larynx/trachea) 3) esophagus 4) recurrent laryngeal nerve. |
| Secondary | Progression free survival (PFS) | Up to 2 years post treatment | Defined as the time from patient registration to disease progression or death from any cause. Structural progression is defined according to RECIST criteria based on histopathologic findings, and biochemical progression is defined as abnormal thyroglobulin (Tg) or rising Tg antibody levels for anaplastic thyroid cancer/differentiated thyroid cancer, and abnormal carcinoembryonic antigen/calcitonin for medullary thyroid cancer. |
| Secondary | Locoregional PFS | Up to 2 years post treatment | Defined as the time from patient registration to locoregional progression or death from any cause. Locoregional progression is defined as disease progression above the clavicles according to modified neck RECIST criteria. |
| Secondary | Surgical morbidity/complexity score | Baseline to the date of surgery, assessed up to 7 months | Surgical morbidity/complexity score will be measured at enrollment, prior to surgery and at surgery. The Thyroid Neck Group Morbidity Complexity Scoring and MGH/MEE-MSK-MD Anderson (MMM) Surgical Morbidity Complexity Score are incorporated, specifying on scale with 5 levels of complexity and mobidity of the surgery \[mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)\]. The surgical morbidity/complexity scores will be collected at enrollment, prior to surgery and at surgery; descriptive statistics such as means and standard deviations will be calculated for each time point. |
| Secondary | Overall survival (OS) | Up to 5 years post treatment | Defined as the time from patient registration to death from any causes. |
| Secondary | Incidence of adverse events | Up to 7 months | Assessed as defined by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. |
| Secondary | Quality of life | Up to 2 years post treatment | Assessed by the European Quality of Life 5 Dimension Questionnaire (EQ-5D). The EQ-5D consists of health state description and evaluation. The health state description consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with each dimension specifying five levels of severity \[best (1)-worst (5)\]. The health state evaluation is assessed using the visual analogue scale (\[worse (0)-best (100)\]. |
| Secondary | Patient-reported outcomes | Up to 2 years post treatment | Measured by the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) instrument. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04759911
GET https://conductscience.org/api/trials/v1/NCT04759911/registered