Trial · NCT01236547
Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer
NCT01236547, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer. Trials, record NCT01236547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01236547
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer
- NCT number
- NCT01236547
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thyroid Gland Anaplastic Carcinoma
- Interventions
- Intensity-Modulated Radiation Therapy, Paclitaxel, Pazopanib Hydrochloride, Placebo Administration
- First posted
- 2010-11-08
- Last updated
- 2022-07-19
- Results first posted
- 2021-05-14
- Limitations and caveats
One run-in arm was originally planned; more run-in arms added due to amendments to the protocol regimen unrelated to toxicities. In addition, due to higher than projected rates of ineligibility and consent withdrawals, phase II final analysis was amended to be time-driven (3 years of potential follow-up for all eligible phase II participants) instead of event driven (71 deaths of eligible phase II participants), reducing power from 80% (one-sided alpha 0.15) to 77% (one-sided alpha 0.1379),
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | (Phase II) Overall Survival | From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Overall survival time is defined as time from randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after all eligible participants were potentially followed for 3 years. |
| Primary | (Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | From registration to last follow-up. Maximum follow-up for run-in and phase II participants at time of analysis was 7.4 years. | Common Terminology Criteria for AEs (version 4.0) grades AE severity from 1=mild to 5=death. Discontinuation of treatment due to toxicity is defined as \< 75% of planned radiation therapy delivered. "Treatment-related" = definitely, probably, or possibly related to treatment. A single run-in arm was originally planned, but additional run-in arms were added due to amendments to the protocol regimen unrelated to toxicities. A two-stage design based on the binomial distribution was used in which the 1st stage analyzes the run-in arm and the 2nd stage analyzes run-in and phase II pazopanib arm participants combined. Because there were multiple run-in arms, only the last is used in the 2nd stage analysis. 1st stage: If ≤4 of 9 participants experience AEC, then conclude treatment is safe. 2nd stage: If ≤8 of 24 participants experience AEC, then conclude treatment safe. Otherwise conclude the treatment is too toxic. Summary data is provided here, see AE Module for specific AE data. |
| Secondary | (Phase II) Local-regional Control | From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. (Statistical analysis compares full distributions therefore all available follow-up was used.) | Local-regional failure is defined as local-regional relapse/progression in the thyroid bed or regional lymph nodes. Time to local-regional failure is defined as time from randomization to the date of first local-regional recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies 6- and 12-month estimates to be reported and for the full distributions of failure times to be compared between the arms. Analysis occurred after all eligible participants were potentially followed for 3 years. |
| Secondary | (Phase II) Percentage of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event, or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern] | From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0) grades adverse event severity from 1=mild to 5=death. Discontinuation of treatment due to toxicity is defined as \< 75% of planned radiation therapy delivered. Adverse events rated as definitely, probably, or possibly related to treatment were considered treatment-related. Summary data is provided in this outcome measure.; See Adverse Events Module for specific adverse event data. |
| Secondary | (Phase II) Percentage of Participants With Treatment-related Grade 3 or 4 Adverse Events Other Than Grade 4 Hemorrhage or Grade 4 Febrile Neutropenia [Not Adverse Events of Concern] | From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events rated as definitely, probably, or possibly related to treatment were considered treatment-related. Summary data is provided in this outcome measure.; See Adverse Events Module for specific adverse event data. |
| Secondary | (Phase II) Percentage of Participants With Complete or Partial Response of the Primary Site After Chemoradiation Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 2-4 weeks after treatment (approximately week 10-14) | Complete Response: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
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 | (Phase II) Overall Survival | From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Eligible participants on phase II arms | percentage of participants | NUMBER |
| PRIMARY | (Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | From registration to last follow-up. Maximum follow-up for run-in and phase II participants at time of analysis was 7.4 years. | First nine eligible participants in run-in each arm and first 15 eligible participants in phase II pazopanib arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | (Phase II) Local-regional Control | From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. (Statistical analysis compares full distributions therefore all available follow-up was used.) | Eligible participants on phase II arms | percentage of participants | NUMBER |
| SECONDARY | (Phase II) Percentage of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event, or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern] | From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Eligible phase II participants who started study treatment | percentage of participants | NUMBER |
| SECONDARY | (Phase II) Percentage of Participants With Treatment-related Grade 3 or 4 Adverse Events Other Than Grade 4 Hemorrhage or Grade 4 Febrile Neutropenia [Not Adverse Events of Concern] | From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. | Eligible phase II participants who started study treatment | percentage of participants | NUMBER |
| SECONDARY | (Phase II) Percentage of Participants With Complete or Partial Response of the Primary Site After Chemoradiation Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 2-4 weeks after treatment (approximately week 10-14) | Eligible participants on phase II arms that with response evaluated | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| (Phase II) Overall Survival | (Phase II) Pazopanib, Paclitaxel, IMRT | 37.1 | 95% Confidence Interval 21.1 to 53.2 | percentage of participants | |
| (Phase II) Overall Survival | (Phase II) Placebo, Paclitaxel, IMRT | 29.0 | 95% Confidence Interval 13.2 to 44.8 | percentage of participants | |
(Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 0 | Participants | ||
(Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 0 | Participants | ||
(Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 2 | Participants | ||
(Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)] | (Phase II) Pazopanib, Paclitaxel, IMRT | 0 | Participants | ||
| (Phase II) Local-regional Control | (Phase II) Pazopanib, Paclitaxel, IMRT | 6 months | 20.0 | 95% Confidence Interval 8.6 to 34.8 | percentage of participants |
| (Phase II) Local-regional Control | (Phase II) Placebo, Paclitaxel, IMRT | 6 months | 27.3 | 95% Confidence Interval 13.3 to 43.3 | percentage of participants |
| (Phase II) Local-regional Control | (Phase II) Pazopanib, Paclitaxel, IMRT | 1 year | 28.6 | 95% Confidence Interval 14.6 to 44.3 | percentage of participants |
| (Phase II) Local-regional Control | (Phase II) Placebo, Paclitaxel, IMRT | 1 year | 33.6 | 95% Confidence Interval 17.9 to 50.0 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 11 | |
| Overall Study | STARTED | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 11 | |
| Overall Study | STARTED | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 12 | |
| Overall Study | STARTED | (Phase II) Pazopanib, Paclitaxel, IMRT | 42 | |
| Overall Study | STARTED | (Phase II) Placebo, Paclitaxel, IMRT | 47 | |
| Overall Study | Eligible | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 11 | |
| Overall Study | Eligible | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 10 | |
| Overall Study | Eligible | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 11 | |
| Overall Study | Eligible | (Phase II) Pazopanib, Paclitaxel, IMRT | 36 | |
| Overall Study | Eligible | (Phase II) Placebo, Paclitaxel, IMRT | 35 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,235
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 | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 8 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 6 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 6 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | (Phase II) Pazopanib, Paclitaxel, IMRT | 15 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | (Phase II) Placebo, Paclitaxel, IMRT | 13 | 34 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 1 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 0 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 0 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | (Phase II) Pazopanib, Paclitaxel, IMRT | 0 | 36 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | (Phase II) Placebo, Paclitaxel, IMRT | 0 | 34 |
1 to 10 of 1,235Source ClinicalTrials.gov
See all 1,235 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 9 | 11 |
| Total, all-cause mortality | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 10 | 10 |
| Total, all-cause mortality | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 11 | 11 |
| Total, all-cause mortality | (Phase II) Pazopanib, Paclitaxel, IMRT | 31 | 36 |
| Total, all-cause mortality | (Phase II) Placebo, Paclitaxel, IMRT | 30 | 34 |
| Total, other adverse events | (Run-in 1) Pazopanib, Paclitaxel, IMRT | 10 | 11 |
| Total, other adverse events | (Run-in 2) Pazopanib, Paclitaxil, IMRT | 10 | 10 |
| Total, other adverse events | (Run-in 3) Pazopanib, Paclitaxel, IMRT | 11 | 11 |
| Total, other adverse events | (Phase II) Pazopanib, Paclitaxel, IMRT | 36 | 36 |
| Total, other adverse events | (Phase II) Placebo, Paclitaxel, IMRT | 33 | 34 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36681089 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
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/NCT01236547
GET https://conductscience.org/api/trials/v1/NCT01236547/flow?page=2