UMIN-CTR Clinical Trial

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

Upper tract urothelial carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

relapse-free survival

Key secondary outcomes

overall survival, intravesical relapse-free survival, adverse events

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

06

Month

24

Day

Date of IRB

2016

Year

08

Month

25

Day

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 related information

Registered date

2016

Year

10

Month

03

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027573