Unique ID issued by UMIN | UMIN000027611 |
---|---|
Receipt number | R000031641 |
Scientific Title | Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer |
Date of disclosure of the study information | 2017/06/02 |
Last modified on | 2022/12/05 22:20:03 |
Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Neoadjuvant chemotherapy for locally advanced upper tract urothelial cancer
Japan |
Upper tract urothelial carcinoma (UTUC)
Urology |
Malignancy
NO
Investigate clinical benefit of neoadjuvant chemotherapy for locally advanced UTUC
Safety,Efficacy
Progression-free survival
Radiologic response, cancer-specific and overall survival, safety, biomarker analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Neoadjuvant chemotherapy for locally advanced UTUC followed by radical nephroureterectomy.
Patients received either gemcitabine 800 mg/m2 on days 1, 8, and 15 plus cisplatin 70 mg/m2 (GCis) on day 2 every 3 wk, or gemcitabine 800 mg/m2 on days 1, 8, and 15 plus carboplatin (GCb) at an area under the curve of 4 according to the Calvert formula on day 2 every 3 wk, for two to four cycles. GCarbo is selected based on renal function (eGFR <60 mL/min/1.73m2) or presence of frailty. To reduce delays in surgery, we planned two courses of NAC and surgery within 90 d in accordance with recommendations for muscle-invasive bladder cancer
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Key inclusion criteria: Patients with locally advanced UTUC who is indicated for radical nephroureterectomy. The indications for NAC were locally advanced UTUC, including cT3-4 disease or local lymph node involvement.
Presence of any distant metastases. History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to neoadjuvant therapy
500
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University School of Medicine
Urology
036-8562
5 zaifu-chou, Hirosaki Japan
0172395091
shingoh@hirosaki-u.ac.jp
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University School of Medicine
Urology
036-8562
5 zaifu-chou, Hirosaki Japan
0172395091
shingoh@hirosaki-u.ac.jp
Hirosaki University School of Medicine
Dept. of Urology
5 zaifu-chou, Hirosaki Japan
Hirosaki University School of Medicine
Dept. of Urology
5 zaifu-chou, Hirosaki Japan
Other
Hirosaki University School of Medicine
Hirosaki
0172-39-5044
rinri@hirosaki-u.ac.jp
NO
2017 | Year | 06 | Month | 02 | Day |
Published
https://pubmed.ncbi.nlm.nih.gov/33484231/
289
The use of NAC for high-risk UTUC increased significantly after 2010. Platinum-based short-term NAC followed by immediate RNU may not impede and potentially improves oncological outcomes.
2022 | Year | 12 | Month | 05 | Day |
Completed
2008 | Year | 01 | Month | 01 | Day |
2021 | Year | 04 | Month | 30 | Day |
2008 | Year | 06 | Month | 01 | Day |
2022 | Year | 12 | Month | 05 | Day |
2017 | Year | 06 | Month | 02 | Day |
2022 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031641
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |