Trial · NCT00104871
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
NCT00104871, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy. Trials, record NCT00104871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00104871
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
- NCT number
- NCT00104871
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
- Interventions
- Bortezomib
- First posted
- 2005-03-04
- Last updated
- 2018-12-19
- Results first posted
- 2014-06-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Tumor Response Rate Assessed by RECIST | Baseline to 12 weeks | Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Primary | Participant Tumor Response Assessed by RECIST | Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks)) | Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Progression-free Survival Assessed by RECIST | At 6 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Tumor Response Rate Assessed by RECIST | Baseline to 12 weeks | Two participants were not evaluable for response. | participants | NUMBER |
| PRIMARY | Participant Tumor Response Assessed by RECIST | Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks)) | Two participants were not evaluable for response. | participants | NUMBER |
| SECONDARY | Progression-free Survival Assessed by RECIST | At 6 months | Two participants were not evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Tumor Response Rate Assessed by RECIST | Bortezomib | 0 | participants | ||
| Participant Tumor Response Assessed by RECIST | Bortezomib | Complete Response | 0 | participants | |
| Participant Tumor Response Assessed by RECIST | Bortezomib | Partial Response | 0 | participants | |
| Participant Tumor Response Assessed by RECIST | Bortezomib | Stable Disease | 11 | participants | |
| Participant Tumor Response Assessed by RECIST | Bortezomib | Progressive Disease | 9 | participants | |
| Progression-free Survival Assessed by RECIST | Bortezomib | 4 | 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 | Bortezomib | 22 | |
| Overall Study | COMPLETED | Bortezomib | 21 | |
| Overall Study | NOT COMPLETED | Bortezomib | 1 |
Source ClinicalTrials.gov
Adverse events133
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 | Abdominal pain | Gastrointestinal disorders | Bortezomib | 1 | 22 | |
| other | Acidosis | Metabolism and nutrition disorders | Bortezomib | 1 | 22 | |
| other | Alanine aminotransferase increased | Investigations | Bortezomib | 3 | 22 | |
| other | Alkaline phosphatase increased | Investigations | Bortezomib | 2 | 22 | |
| other | Anemia | Blood and lymphatic system disorders | Bortezomib | 6 | 22 | |
| other | Anorexia | Metabolism and nutrition disorders | Bortezomib | 7 | 22 | |
| other | Anxiety | Psychiatric disorders | Bortezomib | 4 | 22 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Bortezomib | 1 | 22 | |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Bortezomib | 1 | 22 | |
| other | Aspartate aminotransferase increased | Investigations | Bortezomib | 1 | 22 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib | ||
| Total, other adverse events | Bortezomib | 22 | 22 |
| Total, serious adverse events | Bortezomib | 17 | 22 |
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/NCT00104871
GET https://conductscience.org/api/trials/v1/NCT00104871/events?page=2