Unique ID issued by UMIN | UMIN000018517 |
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Receipt number | R000021355 |
Scientific Title | Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials |
Date of disclosure of the study information | 2015/08/05 |
Last modified on | 2016/09/17 11:38:00 |
Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Cross over trial of GD and GP therapy in metastatic urothelial carcinoma
Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Cross over trial of GD and GP therapy in metastatic urothelial carcinoma
Japan |
metastatic urothelial carcinoma patients after the failure in the cisplatin-based first line systemic chemotherapy
Urology |
Malignancy
NO
Urothelial carcinoma (UC) is considered to be a chemosensitive malignancy. Cisplatin-based systemic chemotherapy is regarded as the gold standard regimens for treating patients with advanced or metastatic UC. For more than a decade, the combination regimens of methotrexate, vinblastine, doxorubicin, cisplatin (M-VAC) and methotrexate, epirubicin, cisplatin (MEC) chemotherapy have been held as the standard in treating advanced or metastatic UC patients. Objective response rates of these regimens were approximately 50% in randomized trials. Recently, combined chemotherapy with gemcitabine and cisplatin (GC) has become another standard treatment for advanced UC. However, long-term follow-up results have revealed that overall survival or progression free survival was never satisfactory, particularly with metastatic UC. There is no standard second-line treatment in patients with metastatic UC after failure of platinum-based chemotherapy. Therefore, in the present study, we evaluated the feasibility, toxicity, and efficacy of sequential therapy using Gemcitabine and docetaxel combination regimen, and Gemcitabine and paclitaxel combination regimen in patients with metastatic UC who were refractory to cisplatin-based first-line chemotherapy.
Efficacy
Confirmatory
Pragmatic
Phase III
overall survival
adverse event
progression free survival
objective response rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Central registration
2
Treatment
Medicine |
GD therapy: gemcitabine 800 mg/m2 administered by a 30 min intravenous infusion on days 1, and 8 and docetaxel 40 mg/m2 also by intravenous infusion on days 1 and 8
gemcitabine 1000 mg/m2 administered by a 30 min intravenous infusion on days 1, 8, and 15, and paclitaxel 200 mg/m2 also by intravenous infusion on days 1
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Eligible patients had histologically proven metastatic UC of the urinary bladder or upper urinary tract. All of the patients had received surgical treatment or been biopsied for the primary lesions. Also, all had one previous chemotherapy treatment that consisted of M-VAC, MEC, or GC. Previous chemotherapy was completed at least 4 weeks before enrollment. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or lower as per the World Health Organization criteria; adequate bone marrow reserve (white blood cell (WBC) count higher than 3,500, platelet count higher than 100,000, and hemoglobin higher than 10 g/dL) was required of all patients. Other requirements were: adequate hepatic function (serum bilirubin 1.5 mg/dl, or less), adequate renal function (serum creatinine 1.5 mg/dl, or measured creatinine clearance of at least 60 ml/min), and an estimated life expectancy of at least 12 weeks. Patients with non-malignant systemic disease that precluded them from receiving therapy, including active infection, any clinically significant cardiac arrhythmia, and/or congestive heart failure, were not eligible. Written informed consent was obtained from all of the patients before this clinical trial.
exclusion criteria patients were below: the patients who had allergy to gemcitabine, and , or taxane derivatives, or patients suspected interstitial lung disease by X ray, or patients who had past history of radiation theapy in chest, or patients suspected infection diseases, or patients who had the possibility of pregnancy, or patients who had uncontrolled cancer diffferent from urothelial cancer.
60
1st name | |
Middle name | |
Last name | Taku Naiki |
Nagoya City University Graduate School of Medical Sciences
Department of Nephro-urology
Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.
052-853-8266
naiki@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Taku Naiki |
Nagoya City University Graduate School of Medical Sciences
Department of Nephro-urology
Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.
052-853-8266
naiki@med.nagoya-cu.ac.jp
Nagoya City University Graduate School of Medical Sciences
none
Other
NO
名古屋市立大学病院
2015 | Year | 08 | Month | 05 | Day |
Unpublished
Open public recruiting
2015 | Year | 08 | Month | 01 | Day |
2015 | Year | 08 | Month | 05 | Day |
2015 | Year | 08 | Month | 01 | Day |
2016 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021355
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