Phase 3
Completed N=615
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Source: ClinicalTrials.gov NCT00375674 ↗Enrolled (actual)
615
Serious AEs
19.5%
Results posted
Aug 2017
Primary outcomePrimary: Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review — 6.8; 5.6 Number of years — p=0.030
◆ Published Evidence
Established
61citations · ~8 / year
Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib.
Summary
To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.
Linked Publications (5)
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Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib.
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Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial.
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Molecular characterization of renal cell carcinoma tumors from a phase III anti-angiogenic adjuvant therapy trial.
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Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting.
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Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review |
6.8; 5.6 | 0.030 sig |
| PRIMARY DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population] |
6.5; 4.5 | 0.077 |
| SECONDARY Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population) |
NA; NA | 0.661 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity |
305; 270; 67; 52; 189; 61 | — |
| SECONDARY Summary of Duration of Treatment-Emergent Adverse Events of Special Interest by MedDRA Preferred Terms (All Causalities, All Cycles) |
35.1; 305.6; 23.2; 110.8; 46.9; 58.0 | — |
| SECONDARY Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores |
74.83; 75.61; 69.71; 75.49; 69.67; 74.09 | — |
| SECONDARY PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison |
83.54; 87.53; 78.94; 85.46; 80.92; 82.97 | — |
| SECONDARY PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison |
29.94; 21.74; 7.35; 3.46; 21.81; 16.63 | — |
| SECONDARY PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population |
0.84; 0.83; 0.83; 0.84; 0.80; 0.82 | — |
| SECONDARY PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means |
77.31; 75.67; 74.39; 76.99; 74.20; 76.85 | — |
| SECONDARY Number of Participants With Tolerability Symptoms |
13; 0; 6; 0; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- High risk renal cancer per modified UISS criteria
- Eastern Cooperative Oncology Group (ECOG) 0-2
- predominant clear cell histology
- No prior anti-cancer treatment
- Kidney tumor has been removed
- No evidence of macroscopic disease following surgery
Exclusion Criteria
- Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
- Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
- known HIV or Hepatitis
- any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Data sourced from ClinicalTrials.gov (NCT00375674) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.