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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00257816 |
There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: Topotecan Drug: Cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Feasibility Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma |
Estimated Enrollment: | 12 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center | 1-877-UC-STUDY | UCstudy@uci.edu |
United States, California | |
Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
Principal Investigator: Bradley Monk, MD |
Principal Investigator: | Bradley Monk, MD | Chao Family Comprehensive Cancer Center |
Responsible Party: | University of California, Irvine Medical Center ( Bradley J. Monk, MD ) |
Study ID Numbers: | UCI 03-33 |
Study First Received: | November 21, 2005 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00257816 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cervical Cancer |
Radiation-Sensitizing Agents Cisplatin Topotecan Carcinoma |
Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Topotecan Pharmacologic Actions |