Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Amendment history

The 50 most recent of 1051 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

1. May 29, 2026

   Minor

   Study Status, References

   Re-verified, no change to tracked fields

   v1051

2. Jan 13, 2022

   Notable

   Primary completion date: Dec 29, 2010 to Aug 27, 2015

   Completion date: Aug 27, 2015 to Sep 1, 2021

   Study Status · v1050

3. Jun 24, 2020

   Minor

   Study Status, IPDSharing, Outcome Measures (Results)

   Re-verified, no change to tracked fields

   v1049

4. May 30, 2019

   Minor

   Study sites: 921 to 987

   Primary completion date: Dec 2010 to Dec 29, 2010; Completion date: Aug 2015 to Aug 27, 2015; Start date: Apr 2006 to Apr 24, 2006; and 5 more

   Show all 9 changes in this update

   • Minor Study sites: 921 to 987
   • Minor Primary completion date: Dec 2010 to Dec 29, 2010
   • Minor Completion date: Aug 2015 to Aug 27, 2015
   • Minor Start date: Apr 2006 to Apr 24, 2006
   • Minor Interventions: Placebo (Other), Sorafenib (Drug), Sunitinib (Drug) to Laboratory Biomarker Analysis (Other), Placebo (Other), Quality-of-Life Assessment (Other), Sorafenib Tosylate (Drug), Sunitinib Malate…
   • Minor Eligibility criteria expanded, about 55 words
     Show what changed

     Pre-Registration Inclusion Criteria: Pre-surgical criteria: Patients must hav [...] ded fully resectable and does not exceed inclusion criteria Patients must have no history of distant metastases No prior anti-cancer therapy for renal cell carcinoma is permitted in either the adjuvant or neoadjuvant setting; this includes metastectomy for renal cell carcinoma, or radiation therapy to the renal bed Patients must not have other current malign [...] ⇅ moved uncontrolled hypertension, myocardial infarction, unstable angina); New York Heart Association grade II or greater congestive heart failure; serious cardiac arrhyt [...] [...]
   • Minor Study description shortened, about 18 words
     Show what changed

     [...] of sunitinib or sorafenib in this patient population. III. To evaluate cardiac function in each arm OTHER PRE-SPECIFIED OBJECTIVES: I. To prospectively collect tumor and biological specimens to a [...] ictors of disease-free survival and of therapeutic benefit. IIIV. To prospectively collect tumor and biological specimens to [...] redictors of disease-free survival and therapeutic benefit. IIIV. To prospectively collect tumor and biological specimens to [...] redictors of disease-free survival and therapeutic benefit. IVVI. To prospectively collect tumor and biological specimens to [...] ofiles as predictors of outcome [...]
   • Minor Collaborators: 4 to 3
     Show what changed

     ECOG-ACRIN Cancer Research Group
   • Minor Publications: 8 to 7
     Show what changed

     Haas NB, Manola J, Ky B, Flaherty KT, Uzzo RG, Kane CJ, Jewett M, Wood L, Wood CG, Atkins MB, Dutcher JJ, Wilding G, DiPaola RS. Effects of Adjuvant Sorafenib and Sunitinib on Cardiac Function in Renal Cell Carcinoma Patients without Overt Metastases: Results from ASSURE, ECOG 2805. Clin Cancer Res. [...]

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing, References · v1048

5. Mar 15, 2019

   Minor

   Site details revised at 2 of 921 sites

   Study Status, Contacts/Locations, References, Baseline Characteristics, Outcome Measures (Results) · v1047

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.