18 and older, any sex, with Clear Cell Renal Cell Carcinoma or Stage I Renal Cell Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Disease-free Survival (DFS)Primary· 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.
Group
Value
95% CI
Arm A (Sunitinib + Sorafenib Placebo)
5.8
5.0 – NA
Arm B (Sorafenib + Sunitinib Placebo)
6.1
4.8 – NA
Arm C (Sunitinib Placebo + Sorafenib Placebo)
6.6
5.3 – 7.8
5-year Overall Survival RateSecondary· 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.
Group
Value
95% CI
Arm A (Sunitinib + Sorafenib Placebo)
0.779
0.741 – 0.819
Arm B (Sorafenib + Sunitinib Placebo)
0.805
0.768 – 0.842
Arm C (Sunitinib Placebo + Sorafenib Placebo)
0.803
0.767 – 0.840
Proportion of Patients With Cardiac EventsSecondary· 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.
Group
Value
95% CI
Arm A (Sunitinib + Sorafenib Placebo)
0.017
0.009 – 0.030
Arm B (Sorafenib + Sunitinib Placebo)
0.013
0.006 – 0.026
Arm C (Sunitinib Placebo + Sorafenib Placebo)
0.008
0.003 – 0.018
5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell HistologySecondary· 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.
Group
Value
95% CI
Arm A (Sunitinib + Sorafenib Placebo)
0.534
0.484 – 0.590
Arm B (Sorafenib + Sunitinib Placebo)
0.527
0.478 – 0.582
Arm C (Sunitinib Placebo + Sorafenib Placebo)
0.560
0.511 – 0.614
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 8 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00326898.