Trial · NCT00326898
Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery
NCT00326898, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2016-12-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery. Trials, record NCT00326898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery
- NCT number
- NCT00326898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,943 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Placebo, Quality-of-Life Assessment, Sorafenib Tosylate, Sunitinib Malate
- First posted
- 2006-05-17
- Last updated
- 2026-06-23
- Results first posted
- 2016-12-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (DFS) | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. |
| Secondary | 5-year Overall Survival Rate | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry | Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate. |
| Secondary | Proportion of Patients With Cardiac Events | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry | Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was \>15% absolute percentage points from baseline within 6 months. |
| Secondary | 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate. |
| Other | The Association Between Angiogenesis Markers and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |
| Other | The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |
| Other | The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |
| Other | The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |
| Other | The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |
| Other | The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival (DFS) | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | All randomized patients | years | MEDIAN |
| SECONDARY | 5-year Overall Survival Rate | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry | All randomized patients | proportion of participants | NUMBER |
| SECONDARY | Proportion of Patients With Cardiac Events | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry | Patients with at least 1 follow-up MUGA scan were included in this analysis. | Proportion of participants | NUMBER |
| SECONDARY | 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | Patients with clear cell histology were included in this analysis. | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | The Association Between Angiogenesis Markers and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |||
| OTHER_PRE_SPECIFIED | The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |||
| OTHER_PRE_SPECIFIED | The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |||
| OTHER_PRE_SPECIFIED | The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |||
| OTHER_PRE_SPECIFIED | The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry | |||
| OTHER_PRE_SPECIFIED | The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (DFS) | Arm A (Sunitinib + Sorafenib Placebo) | 5.8 | 97.5% Confidence Interval 5.0 to NA | years | |
| Disease-free Survival (DFS) | Arm B (Sorafenib + Sunitinib Placebo) | 6.1 | 97.5% Confidence Interval 4.8 to NA | years | |
| Disease-free Survival (DFS) | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 6.6 | 97.5% Confidence Interval 5.3 to 7.8 | years | |
| 5-year Overall Survival Rate | Arm A (Sunitinib + Sorafenib Placebo) | 0.779 | 97.5% Confidence Interval 0.741 to 0.819 | proportion of participants | |
| 5-year Overall Survival Rate | Arm B (Sorafenib + Sunitinib Placebo) | 0.805 | 97.5% Confidence Interval 0.768 to 0.842 | proportion of participants | |
| 5-year Overall Survival Rate | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 0.803 | 97.5% Confidence Interval 0.767 to 0.840 | proportion of participants | |
| Proportion of Patients With Cardiac Events | Arm A (Sunitinib + Sorafenib Placebo) | 0.017 | 90% Confidence Interval 0.009 to 0.030 | Proportion of participants | |
| Proportion of Patients With Cardiac Events | Arm B (Sorafenib + Sunitinib Placebo) | 0.013 | 90% Confidence Interval 0.006 to 0.026 | Proportion of participants | |
| Proportion of Patients With Cardiac Events | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 0.008 | 90% Confidence Interval 0.003 to 0.018 | Proportion of participants | |
| 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology | Arm A (Sunitinib + Sorafenib Placebo) | 0.534 | 97.5% Confidence Interval 0.484 to 0.590 | proportion of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Sunitinib + Sorafenib Placebo) | 647 | |
| Overall Study | STARTED | Arm B (Sorafenib + Sunitinib Placebo) | 649 | |
| Overall Study | STARTED | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 647 | |
| Overall Study | Patients With Toxicity Data | Arm A (Sunitinib + Sorafenib Placebo) | 625 | |
| Overall Study | Patients With Toxicity Data | Arm B (Sorafenib + Sunitinib Placebo) | 628 | |
| Overall Study | Patients With Toxicity Data | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 626 | |
| Overall Study | Patients With Clear Cell Histology | Arm A (Sunitinib + Sorafenib Placebo) | 542 | |
| Overall Study | Patients With Clear Cell Histology | Arm B (Sorafenib + Sunitinib Placebo) | 540 | |
| Overall Study | Patients With Clear Cell Histology | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 540 | |
| Overall Study | Patients With >=1 Follow-up MUGA Scan | Arm A (Sunitinib + Sorafenib Placebo) | 513 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events459
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 | Arm A (Sunitinib + Sorafenib Placebo) | 38 | 625 | |
| other | Hypertension | Vascular disorders | Arm B (Sorafenib + Sunitinib Placebo) | 38 | 628 | |
| other | Hypertension | Vascular disorders | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 10 | 626 | |
| other | Fatigue | General disorders | Arm A (Sunitinib + Sorafenib Placebo) | 62 | 625 | |
| other | Fatigue | General disorders | Arm B (Sorafenib + Sunitinib Placebo) | 58 | 628 | |
| other | Fatigue | General disorders | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 31 | 626 | |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Arm A (Sunitinib + Sorafenib Placebo) | 17 | 625 | |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Arm B (Sorafenib + Sunitinib Placebo) | 43 | 628 | |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 15 | 626 | |
| other | Hand-foot reaction | Skin and subcutaneous tissue disorders | Arm A (Sunitinib + Sorafenib Placebo) | 36 | 625 |
1 to 10 of 459Source ClinicalTrials.gov
See all 459 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Sunitinib + Sorafenib Placebo) | ||
| Total, all-cause mortality | Arm B (Sorafenib + Sunitinib Placebo) | ||
| Total, all-cause mortality | Arm C (Sunitinib Placebo + Sorafenib Placebo) | ||
| Total, other adverse events | Arm A (Sunitinib + Sorafenib Placebo) | 116 | 625 |
| Total, other adverse events | Arm B (Sorafenib + Sunitinib Placebo) | 117 | 628 |
| Total, other adverse events | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 57 | 626 |
| Total, serious adverse events | Arm A (Sunitinib + Sorafenib Placebo) | 368 | 625 |
| Total, serious adverse events | Arm B (Sorafenib + Sunitinib Placebo) | 424 | 628 |
| Total, serious adverse events | Arm C (Sunitinib Placebo + Sorafenib Placebo) | 81 | 626 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | 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/NCT00326898
GET https://conductscience.org/api/trials/v1/NCT00326898/events?page=2