Unique ID issued by UMIN | UMIN000002450 |
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Receipt number | R000002640 |
Scientific Title | Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study |
Date of disclosure of the study information | 2009/10/01 |
Last modified on | 2012/09/28 23:40:17 |
Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer
Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer
Japan |
Urothelial cancer
Hematology and clinical oncology | Urology |
Malignancy
NO
To compare the responsive rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
Safety
To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
gemcitabine/paclitaxel combination therapy
gemcitabine monotherapy
18 | years-old | <= |
Not applicable |
Male and Female
1. Urothelial cancer was (must be) confirmed by histological or cytological methods. 2. Locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery 3. Patients had measurable diseases. 4. Regardless of the objectives, CDDP-resistant urothelial cancer. 5. PS 0-2 6. Prior chemotherapy with gemcitabine or paclitaxel was not allowed. 7. major organ function were maintained
1. prior chemotherapy with gemcitabine or paclitaxel
2. patients with interstitial pneumoniae and pulmonary fibrosis
3. patients with body fluid with the necessity of drainage or severe edema
4. patients with brain metastasis with the necessity of treatment
5. active double cancer
6. severe or uncontrollable complications
7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins)
8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy
9. Prior therapy is allowed if this is
completed more than 28 days before study entry.
10. Otherwise, patients are judged to be not eligible by the attending doctor.
80
1st name | |
Middle name | |
Last name | Shigeo Horie |
Teikyo University, School of Medicine
Department of Urology
2-11-1, Kaga, Itabashi-ku
1st name | |
Middle name | |
Last name |
Teikyo University, School of Medicine
Department of Urology
muto@med.teikyo-u.ac.jp
Teikyo University
Teikyo University
Self funding
NO
2009 | Year | 10 | Month | 01 | Day |
Unpublished
Terminated
2009 | Year | 07 | Month | 06 | Day |
2009 | Year | 07 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2009 | Year | 09 | Month | 05 | Day |
2012 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002640
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