UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Upper tract urothelial carcinoma
Classification by specialty	Urology
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	Medicine
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+.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
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.
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.
Target sample size	310

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiyuki Kakehi
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
Email	kakehi@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akihiro Ito/Yoichi Arai
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/
Email	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

Other related organizations
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IRB Contact (For public release)
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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）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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Baseline Characteristics
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Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 03 Day
Last follow-up date	2025 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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Management information
Registered date	2016 Year 10 Month 03 Day
Last modified on	2016 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027573

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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