Trial · NCT01158521
Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer
NCT01158521, Phase 2, Completed, Case Comprehensive Cancer Center; results first posted 2018-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer. Trials, record NCT01158521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01158521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer
- NCT number
- NCT01158521
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Case Comprehensive Cancer Center
- Conditions
- Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer, Stage III Renal Cell Cancer
- Interventions
- pazopanib hydrochloride, therapeutic conventional surgery
- First posted
- 2010-07-08
- Last updated
- 2018-09-12
- Results first posted
- 2018-09-12
- Limitations and caveats
Requires further prospective study. Moreover, in this study, assessment of if partial nephrectomy is feasible prior to surgery was based on subjective measures. Outcome of subjects if they did not receive neoadjuvant therapy is unknown.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy | Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks. | The primary end point was the percentage of patients who could undergo partial nephrectomy after pazopanib therapy. A reduction in tumor size, with pazopanib treatment, may permit the use of a partial nephrectomy, as opposed to a radical nephrectomy. This would help preserve additional vascularized parenchyma. |
| Secondary | Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment. | After 8 to 16-weeks of pazopanib therapy and 7 day washout prior to surgery. | Measurement of total parenchymal tissue that could be saved with pazopanib therapy and subsequent surgery, which was performed via a volumetric analysis of CT images. |
| Secondary | Change in Tumor Diameter | At the conclusion of 8 to 16-week treatment with pazopanib therapy. | Median (cm) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment). |
| Secondary | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR | At the end of 8 to 16-weeks of treatment | Efficacy of pazopanib was evaluated via the Response Evaluation Criteria in Solid Tumors, version 1.1. Assessed by MRI. Definitions of response include Complete Response (CR), Disappearance of target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR |
| Secondary | Surgical Morbidity | post-surgery | Conversion of tumor post therapy so that there is \< 10% risk that a partial nephrectomy would be associated with a high risk of significant postoperative morbidity (e.g. conversion of tumor post therapy to ≥ 3 mm away from renal hilum (main renal artery, renal vein, or primary branches) |
| Secondary | Reduction in Tumor Volume After Treatment | After 8 to 16-weeks of pazopanib treatment | Median (cm\^3) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment). |
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 | Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy | Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment. | After 8 to 16-weeks of pazopanib therapy and 7 day washout prior to surgery. | cm^3 | MEAN | |
| SECONDARY | Change in Tumor Diameter | At the conclusion of 8 to 16-week treatment with pazopanib therapy. | cm | MEDIAN | |
| SECONDARY | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR | At the end of 8 to 16-weeks of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Surgical Morbidity | post-surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduction in Tumor Volume After Treatment | After 8 to 16-weeks of pazopanib treatment | cm^3 | MEAN |
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 |
|---|---|---|---|---|---|
| Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy | Arm I | 6 | Participants | ||
| Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment. | Treatment Group | 173 | Inter-Quartile Range 127 to 238 | cm^3 | |
| Change in Tumor Diameter | Treatment Group | 5.5 | Inter-Quartile Range 1.8 to 8.3 | cm | |
| Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR | Treatment Group | 10 | Participants | ||
| Surgical Morbidity | Treatment Group | 16 | Participants | ||
| Reduction in Tumor Volume After Treatment | Treatment Group | 92 | Inter-Quartile Range 50 to 118 | cm^3 |
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 | Treatment Group | 25 | |
| Overall Study | COMPLETED | Treatment Group | 25 | |
| Overall Study | NOT COMPLETED | Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | Hypertension | Vascular disorders | Treatment Group | 9 | 25 | |
| other | Elevated Liver Enzymes | Hepatobiliary disorders | Treatment Group | 5 | 25 | |
| other | Fatigue | General disorders | Treatment Group | 2 | 25 | |
| other | Thrombocytepenia | Blood and lymphatic system disorders | Treatment Group | 1 | 25 | |
| other | Fatigue | General disorders | Treatment Group | 19 | 25 | |
| other | Liver enzymes | Hepatobiliary disorders | Treatment Group | 12 | 25 | |
| other | Hypertension | Vascular disorders | Treatment Group | 4 | 25 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment Group | 13 | 25 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment Group | 12 | 25 | |
| other | Taste Change | General disorders | Treatment Group | 12 | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group | 0 | 25 |
| Total, other adverse events | Treatment Group | 25 | 25 |
| Total, serious adverse events | Treatment Group | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25532471 | 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/NCT01158521
GET https://conductscience.org/api/trials/v1/NCT01158521/registered