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NCT00326898 · ClinicalTrials.gov registry record · Phase 3
Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery
A Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,943
- Enrollment target
- 20
- Study locations
NCT00326898: Completed Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT00326898 is a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,943 participants, above the 160-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (1114% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326898, a Phase 3 study of Clear Cell Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,943 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Sorafenib Tosylate
- DRUG Sunitinib Malate
Study Locations (20)
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Clearview Cancer Institute - Huntsville
- Mobile Infirmary Medical Center - Mobile
- Providence Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Banner Thunderbird Medical Center - Glendale
- Banner-University Medical Center Phoenix - Phoenix
- Western Regional CCOP - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
Arkansas
- Sparks Regional Medical Center - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group-Rogers - Rogers
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mills-Peninsula Medical Center - Burlingame
- East Bay Radiation Oncology Center - Castro Valley
Alaska
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,943 participants |
| Start Date | 2006-04-24 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 3 |
What the finished NCT00326898 record still lists
NCT00326898 is an interventional study that assigns participants to a tested intervention. Its 1,943 participants enrollment target places it among the larger protocols in the corpus, above the 160-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (1114% higher).
The record links to 4 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT00326898 names 20 study sites across 5 states, led by Alabama, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00326898 about?
NCT00326898 is a clinical study titled "Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery". 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 enz...
What is the current status of trial NCT00326898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,943 participants. The study started on 2006-04-24. Estimated completion is 2021-09-01.
What conditions does trial NCT00326898 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage II Renal Cell Cancer AJCC v7, Stage I Renal Cell Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT00326898?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Sorafenib Tosylate (DRUG), Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT00326898?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00326898 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Clear Cell Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00326898's enrollment target sits among peer trials
1,943 1st of 45 higher than 45 of 45 other Clear Cell Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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