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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00696007 |
The purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.
Condition | Intervention | Phase |
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Transitional Cell Carcinoma |
Drug: Gemcitabine and cisplatin Other: Retrospective comparison |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2019 |
Estimated Primary Completion Date: | April 2018 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
A neoadjuvant chemotherapy (gemcitabine and cisplatin) regimen administered before surgery-nephroureterectomy for upper tract TCC
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Drug: Gemcitabine and cisplatin
Neoadjuvant chemotherapy (gemcitabine and cisplatin) administered before Nephroureterectomy. Chemotherapy regimen of three cycles of gemcitabine and cisplatin, dosed over a 3 month period Each cycle would consist of gemcitabine and cisplatin on day 1, with two other doses of gemcitabine on day 8 and day 15. Gemcitabine dosing would be 1,000 mg/m² and cisplatin would be dosed at 70 mg/m² |
2
A retrospective cohort group (approximately 60 subjects) identified from an institutional cancer registry who have undergone a nephroureterectomy alone over the past five years
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Other: Retrospective comparison
60 retrospective historical cohort group of subjects who have undergone a radical nephroureterectomy over the past five years
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This study will look at improving overall survival of those undergoing nephroureterectomy for upper tract TCC (transitional cell carcinoma, comparing the pathological response of tumors treated with Neoadjuvant Chemotherapy (gemcitabine and cisplatin) before surgery. There have been reported studies of neoadjuvant chemotherapy in the treatment of upper tract TCC, there have been no studies to date that include the chemotherapy agents gemcitabine and cisplatin that are currently indicated in treating TCC of the bladder in the neoadjuvant and adjuvant setting. These agents have been proven to have a better overall safety profile and tolerability allowing more patients to complete their regimens. Secondarily, study will compare disease free overall survival among patients treated with neoadjuvant chemotherapy and surgery versus surgery alone. This study may elucidate the potential benefit of these agents when treating TCC of the upper tracts and may provide a survival advantage in this specific patient population as compared to a historical cohort.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher G. Tretter, M.D. | 781-744-8410 | Christopher.G.Tretter@Lahey.org |
Contact: Krista V. Marcello | 781-744-3071 | Krista.V.Marcello@Lahey.org |
United States, Massachusetts | |
Lahey Clinic, Inc. | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Contact: Christopher G. Tretter, M.D. 781-744-8410 Christopher.G.Tretter@Lahey.org | |
Contact: Krista V. Marcello 781-744-3071 Krista.V.Marcello@Lahey.org | |
Sub-Investigator: Alireza Moinzadeh, M.D. | |
Sub-Investigator: Justin Gould, M.D. | |
Sub-Investigator: Andrea Sorcini, M.D. | |
Sub-Investigator: John Libertino, M.D. | |
Sub-Investigator: Ingolf Tuerk, M.D. | |
Sub-Investigator: Timothy Cooley, M.D. |
Principal Investigator: | Christopher G. Tretter, M.D. | Lahey Clinic, Inc. |
Responsible Party: | Lahey Clinic, Inc. ( Christopher G. Tretter, M.D. ) |
Study ID Numbers: | 2008-039 |
Study First Received: | June 10, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00696007 |
Health Authority: | United States: Institutional Review Board |
Upper GU Tract Transitional Cell Carinoma Nephroureterectomy Chemotherapy Gemcitabine Cisplatin |
Cisplatin Gemcitabine Carcinoma, Transitional Cell |
Transitional cell carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |