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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000024267 |
Receipt No. | R000027573 |
Scientific Title | Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) |
Date of disclosure of the study information | 2016/10/03 |
Last modified on | 2021/01/05 |
Basic information | ||
Public title | Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) | |
Acronym | Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) | |
Scientific Title | Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) | |
Scientific Title:Acronym | Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) | |
Region |
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Condition | ||
Condition | Upper tract urothelial carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To confirm the efficacy and safety of intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after radical nephroureterectomy for stage 0a-III (cTa-T3N0M0) upper tract urothelial carcinoma |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | relapse-free survival |
Key secondary outcomes | overall survival, intravesical relapse-free survival, adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A: No instillation following radical nephroureterectomy. Postoperative chemotherapy of 2 cycles of gemcitabine at 1000 mg/m2 and cisplatin at 70 mg/m2 every 4 weeks for only high risk patients with pT3/T4 or pN+. | |
Interventions/Control_2 | B: Intravesical instillation of pirarubicin (THP) at 30 mg following radical nephroureterectomy.
Postoperative chemotherapy of 2 cycles of gemcitabine at 1000 mg/m2 and cisplatin at 70 mg/m2 every 4 weeks for only high risk patients with pT3/T4 or pN+. |
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Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | "First registration
1. Upper tract urothelial carcinoma diagnosed by CT with fulfilling all of the followings: i) primary site is located in the renal pelvis or the ureter, ii) not bilateral. 2. Clinical stage 0a-III(cTa-T3N0M0)diagnosed by CT 3. Aged 20 to 80 years old. 4. ECOG performance status (PS) of 0 or 1. 5. No history of upper tract urothelial carcinoma. 6. No bladder cancer diagnosed by cystoscopy. 7. No history of bladder cancer. 8. No history of irradiation including the bladder. 9. The intact kidney is functioning.. 10. Sufficient organ functions. 11. Written informed consent. Second registration 1. Macroscopically proven Ta-3N0M0. 2. No lymph node metastasis if pathological examination during surgery is conducted. 3. No serious intraoperative complication. 4. No leak after bladder wall resection of the ureteral orifice site. 5. Resection margin of the ureter is macroscopically negative. 6. Within 56 days from the date of cystoscopy. 7. Within 91 days from the date of CT. |
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Key exclusion criteria | First registration (no exclusion criteria at second registration)
1. Synchronous or metachronous (within 5 years) malignancies. 2. Infectious disease requiring systemic treatment. 3. Pyrexia of 38 degrees centigrade or higher. 4. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5. Severe psychological disorder. 6. Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7. History of abnormal cardiac function or having received the limit dose of medications with cardiac toxicity such as anthracyclines. 8. Positive HIV antibody. |
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Target sample size | 310 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kagawa University Faculty of Medicine | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan | ||||||
TEL | 087-891-2202 | ||||||
kakehi@med.kagawa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | JCOG1403 Coordinating Office | ||||||
Division name | Department of Urology, Tohoku University Graduate School of Medicine | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi Prefecture, 980-8574 Japan | ||||||
TEL | 022-717-7278 | ||||||
Homepage URL | http://www.jcog.jp/ | ||||||
JCOG_sir@ml.jcog.jp |
Sponsor | |
Institute | Japan Clinical Oncology Group (JCOG) |
Institute | |
Department |
Funding Source | |
Organization | National Cancer Center |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道大学病院(北海道)
札幌医科大学(北海道) 函館厚生院函館五稜郭病院(北海道) 弘前大学医学部附属病院(青森県) 東北大学病院(宮城県) 宮城県立がんセンター(宮城県) 秋田大学医学部(秋田県) 山形大学医学部(山形県) 筑波大学医学医療系(茨城県) 栃木県立がんセンター(栃木県) 防衛医科大学校(埼玉県) 国立がん研究センター東病院(千葉県) 千葉大学医学部(千葉県) 国立がん研究センター中央病院(東京都) 東京慈恵会医科大学附属病院(東京都) 帝京大学医学部(東京都) 横浜市立大学附属市民総合医療センター(神奈川県) 新潟県立がんセンター新潟病院(新潟県) 新潟大学医歯学総合病院(新潟県) 山梨大学医学部(山梨県) 信州大学医学部(長野県) 浜松医科大学(静岡県) 静岡県立静岡がんセンター(静岡県) 名古屋大学医学部(愛知県) 三重大学医学部(三重県) 京都大学医学部附属病院(京都府) 大阪大学医学部(大阪府) 大阪府立病院機構大阪府立成人病センター(大阪府) 神戸大学医学部(兵庫県) 奈良県立医科大学(奈良県) 鳥取大学医学部(鳥取県) 島根大学医学部(島根県) 山口大学医学部附属病院(山口県) 香川大学医学部(香川県) 国立病院機構四国がんセンター(愛媛県) 久留米大学医学部(福岡県) 九州大学病院(福岡県) 原三信病院(福岡県) 熊本大学医学部(熊本県) 大分大学医学部附属病院(大分県) 宮崎大学医学部附属病院(宮崎県) 鹿児島大学医学部・歯学部附属病院(鹿児島県) |
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Publication of results | Unpublished |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027573 |
Research Plan | |
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