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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B Southwest Oncology Group NCIC Clinical Trials Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00326898 |
Purpose
RATIONALE: Sunitinib and sorafenib 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 or sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: sorafenib tosylate Drug: sunitinib malate Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma |
| Estimated Enrollment: | 1923 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Patients receive oral sunitinib malate once daily for 4 weeks followed by rest for 2 weeks and oral placebo for sorafenib twice daily for 6 weeks.
|
Drug: sunitinib malate
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm B
Patients receive oral sorafenib twice daily for 6 weeks and oral placebo for sunitinib malate once daily for 4 weeks followed by rest for 2 weeks..
|
Drug: sorafenib tosylate
Given orally
Other: placebo
Given orally
|
|
Placebo Comparator: Arm C
Patients receive oral placebo for sorafenib as in arm A and oral placebo for sunitinib malate as in arm B.
|
Other: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, multicenter study. Patients who have not had surgical resection undergo radical or partial nephrectomy first. Patients are then stratified according to risk (intermediate high-risk vs very high-risk), histology (clear cell vs non-clear cell [except collecting duct or medullary]), ECOG performance status (0 vs 1), and the type of nephrectomy (laparoscopic vs open). Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Tumor tissue is collected prior to or during nephrectomy. Blood and urine samples are collected at baseline and periodically during study for biomarker correlative studies.
Patients complete quality of life questionnaires, the FACIT-fatigue scale and the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue form, at baseline, and after courses 2 and 4 of treatment.
After completion of study treatment, patients are followed periodically for 9 years.
PROJECTED ACCRUAL: A total of 1,923 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma, including any of the following subtypes:
Nonclear cell carcinoma
Meets 1 of the following risk categories:
Intermediate high-risk disease
Very high-risk disease
Planning to start study treatment between 4-12 weeks after radical or partial nephrectomy
Underwent full surgical resection (i.e., radical or partial nephrectomy) by either open or laparoscopic technique within the past 3-10 weeks
Planning to undergo the above surgical resection AND meets all of the following criteria:
pT1b-4, N0 or any fully resectable N (i.e., N1-2), M0 disease by radiologic criteria, meeting any of the following criteria:
No evidence of residual or metastatic renal cell cancer by chest, abdomen, and pelvic CT scan with oral and IV contrast (or MRI scan of the abdomen and pelvis with gadolinium and a CT scan of the chest with or without IV contrast) within 4 weeks of randomization (after radical or partial nephrectomy)
PATIENT CHARACTERISTICS:
No serious intercurrent illness, including, but not limited to, any of the following:
At least 6 months since any of the following:
PRIOR CONCURRENT THERAPY:
No prior anticancer therapy for renal cell carcinoma in either the adjuvant or neoadjuvant setting, including any of the following:
At least 2 weeks since prior and no concurrent treatment with any of the following*:
Contacts and Locations
Show 813 Study Locations| Study Chair: | Naomi S. Balzer-Haas, MD | Abramson Cancer Center of the University of Pennsylvania |
| Investigator: | Keith T. Flaherty, MD | Abramson Cancer Center of the University of Pennsylvania |
| Investigator: | Robert Uzzo, MD | Fox Chase Cancer Center |
| Study Chair: | Christopher J. Kane, MD | University of California, San Francisco |
| Study Chair: | Christopher G. Wood, MD | M.D. Anderson Cancer Center |
| Study Chair: | Michael A.S. Jewett, MD | Princess Margaret Hospital, Canada |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00326898 History of Changes |
| Other Study ID Numbers: | CDR0000478976, ECOG-E2805, CALGB-E2805, SWOG-E2805, CAN-NCIC-E2805 |
| Study First Received: | May 16, 2006 |
| Last Updated: | September 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
clear cell renal cell carcinoma stage I renal cell cancer stage II renal cell cancer |
stage III renal cell cancer stage IV renal cell cancer papillary renal cell carcinoma |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Sorafenib |
Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |