Trial · NCT00936858
RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
NCT00936858, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2021-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RAD001 for Patients With Radioiodine Refractory Thyroid Cancer. Trials, record NCT00936858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00936858
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
- NCT number
- NCT00936858
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Thyroid Cancer
- Interventions
- RAD001
- First posted
- 2009-07-10
- Last updated
- 2026-08-12
- Results first posted
- 2021-09-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. | Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. |
| Secondary | Objective Response Rate | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. | The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. PR or better is achieved if the following are true: Target Lesions: -At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Bone Lesions: -\>50% increase in lesions. -No new lesions. |
| Secondary | Median Overall Survival | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 5 years post study registration. | Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. |
| Secondary | Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only] | Measured at baseline and then again at cycle 8 (8 months). | The M. D. Anderson Symptom Inventory (MDASI) questionnaire was used to assess quality of life. Questions 1 to 19 were scored. Each of the 19 questions have a response range of 0 - 10, where 0 represents "not present" and 10 represents "as bad as you can imagine". The 19 responses are averaged together to create a mean score, with a lower score indicating a better quality of life. All questionnaire mean scores at each timepoint are averaged together to give a mean score at that timepoint (baseline and week 8) The mean change in quality of life is calculated by subtracting the baseline mean score from the week 8 mean score. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. | months | MEDIAN | |
| SECONDARY | Objective Response Rate | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months. | percentage of participants | NUMBER | |
| SECONDARY | Median Overall Survival | Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 5 years post study registration. | months | MEDIAN | |
| SECONDARY | Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only] | Measured at baseline and then again at cycle 8 (8 months). | Only 8 of the 10 participants with Medullary Thyroid Cancer filled out both questionnaires (one at baseline and one at cycle 8). | mean change in score on the MDASI scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression Free Survival | Arm A | 12.5 | 95% Confidence Interval 7.2 to 17.5 | months | |
| Objective Response Rate | Arm A | 6 | 95% Confidence Interval 0 to 12.6 | percentage of participants | |
| Median Overall Survival | Arm A | 32.7 | 95% Confidence Interval 18.7 to 61.3 | months | |
| Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only] | Arm A | -0.0621 | Standard Deviation 0.992 | mean change in score on the MDASI scale |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RAD001 Group | 50 | |
| Overall Study | Participants With Medullary Thyroid Cancer | RAD001 Group | 10 | |
| Overall Study | COMPLETED | RAD001 Group | 0 | |
| Overall Study | NOT COMPLETED | RAD001 Group | 50 |
Source ClinicalTrials.gov
Adverse events233
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 | Cardiac-ischemia | Cardiac disorders | Arm A | 1 | 50 | |
| other | Pericardial effusion (non-malignant) | Cardiac disorders | Arm A | 2 | 50 | |
| other | Tootheache | Gastrointestinal disorders | Arm A | 1 | 50 | |
| other | Dysgeunsia | Nervous system disorders | Arm A | 1 | 50 | |
| other | Vascular Disorder - Other | Vascular disorders | Arm A | 1 | 50 | |
| other | Infection Gr0-2 neut, upper airway | Infections and infestations | Arm A | 2 | 50 | |
| other | Infection w/ unk ANC lung | Infections and infestations | Arm A | 1 | 50 | |
| other | Infection w/ unk ANC upper airway NOS | Infections and infestations | Arm A | 1 | 50 | |
| other | Infection w/ unk ANC urinary tract NOS | Infections and infestations | Arm A | 1 | 50 | |
| other | Hypokalemia | Metabolism and nutrition disorders | Arm A | 1 | 50 |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 3 | 50 |
| Total, other adverse events | Arm A | 50 | 50 |
| Total, serious adverse events | Arm A | 36 | 50 |
Source ClinicalTrials.gov
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/NCT00936858
GET https://conductscience.org/api/trials/v1/NCT00936858/events?page=2