Trial · NCT01120249

S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

NCT01120249, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2024-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery. Trials, record NCT01120249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01120249

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
NCT number: NCT01120249
Status: Completed
Phases: Phase 3
Enrollment: 1,545 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Kidney Cancer
Interventions: everolimus, placebo
First posted: 2010-05-10
Last updated: 2025-09-16
Results first posted: 2024-03-20

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	5-year Recurrence-free Survival (RFS)	5 years from registration	To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.
Secondary	5-year Overall Survival (OS)	5 years from registration	To compare 5-year overall survival in those patients randomized to everolimus versus those randomized to placebo. Overall survival is defined as time from date of registration to date of death due to any cause or patients last known to be alive are censored at their last contact date.
Secondary	Frequency and Severity of Toxicities	Up to 54 weeks of treatment	Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported. Measured using CTCAE v4.0.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	5-year Recurrence-free Survival (RFS)	5 years from registration	1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).	percentage of paticipants	NUMBER
SECONDARY	5-year Overall Survival (OS)	5 years from registration	1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).	percentage of paticipants	NUMBER
SECONDARY	Frequency and Severity of Toxicities	Up to 54 weeks of treatment	Participants who received at least one dose of protocol treatment and were not excluded from safety analysis per the study chairs request.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group190

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
5-year Recurrence-free Survival (RFS)	Placebo		63	95% Confidence Interval 60 to 67	percentage of paticipants
5-year Recurrence-free Survival (RFS)	Everolimus		67	95% Confidence Interval 63 to 70	percentage of paticipants
5-year Overall Survival (OS)	Placebo		85	95% Confidence Interval 82 to 87	percentage of paticipants
5-year Overall Survival (OS)	Everolimus		87	95% Confidence Interval 84 to 89	percentage of paticipants
Frequency and Severity of Toxicities	Placebo	Abdominal infection	0		Participants
Frequency and Severity of Toxicities	Everolimus	Abdominal infection	1		Participants
Frequency and Severity of Toxicities	Placebo	Abdominal pain	0		Participants
Frequency and Severity of Toxicities	Everolimus	Abdominal pain	7		Participants
Frequency and Severity of Toxicities	Placebo	Acidosis	1		Participants
Frequency and Severity of Toxicities	Everolimus	Acidosis	0		Participants

1 to 10 of 190Source ClinicalTrials.gov

See all 190 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	744
Overall Study	STARTED	Everolimus	755
Overall Study	COMPLETED	Placebo	512
Overall Study	COMPLETED	Everolimus	343
Overall Study	NOT COMPLETED	Placebo	232
Overall Study	NOT COMPLETED	Everolimus	412

Source ClinicalTrials.gov

Adverse events406

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
other	Anemia	Blood and lymphatic system disorders	Placebo	151	723
other	Anemia	Blood and lymphatic system disorders	Everolimus	364	740
other	Abdominal pain	Gastrointestinal disorders	Placebo	111	723
other	Abdominal pain	Gastrointestinal disorders	Everolimus	137	740
other	Constipation	Gastrointestinal disorders	Placebo	86	723
other	Constipation	Gastrointestinal disorders	Everolimus	86	740
other	Diarrhea	Gastrointestinal disorders	Placebo	145	723
other	Diarrhea	Gastrointestinal disorders	Everolimus	289	740
other	Dry mouth	Gastrointestinal disorders	Placebo	37	723
other	Dry mouth	Gastrointestinal disorders	Everolimus	55	740

1 to 10 of 406Source ClinicalTrials.gov

See all 406 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	151	744
Total, all-cause mortality	Everolimus	139	755
Total, other adverse events	Placebo	649	723
Total, other adverse events	Everolimus	716	740
Total, serious adverse events	Placebo	68	723
Total, serious adverse events	Everolimus	154	740

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37524096	DERIVED	PubMed
39106067	DERIVED	PubMed

Grants1

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
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Everolimus vs Placebo: deaths from any cause	Trial comparisons
Everolimus vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01120249

GET https://conductscience.org/api/trials/v1/NCT01120249/results?page=2

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