Unique ID issued by UMIN | C000000364 |
---|---|
Receipt number | R000000465 |
Scientific Title | A randomized study of intravesical BCG therapy for superficial bladder cancer -The comparative study for low doses of BCG treatment- |
Date of disclosure of the study information | 2006/03/24 |
Last modified on | 2013/03/27 14:25:56 |
A randomized study of intravesical BCG therapy for superficial bladder cancer
-The comparative study for low doses of BCG treatment-
A clinical study of intravesical BCG therapy
A randomized study of intravesical BCG therapy for superficial bladder cancer
-The comparative study for low doses of BCG treatment-
A clinical study of intravesical BCG therapy
Japan |
Superficial bladder cancer (Ta or T1, Grade1-2)
Urology |
Malignancy
NO
To evaluate recurrence prevention effect and safety of intravesical BCG-connaught strain (27mg or 13.5mg) treatment following transurethral resection of a bladder tumor (TURBT) in patients with superficial bladder cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
recurrence-free survival
Relation between the incidence of fever (over 37 degrees C) and non-recurrence rate
Adverse drug reactions
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
Central registration
3
Treatment
Medicine |
A: After TURBT, administering 27mg/41mL of BCG-connaught strain intravesically once a week, 6 times in total
B: After TURBT, administering 13.5mg/40.5mL of BCG-connaught strain intravesically once a week, 6 times in total
C: TURBT alone
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Patients aged between 20 and 85 at the time of registration
2) Patients with Performance Status (P.S.) levels of 0 to 2 [ECOG (Zubrod) score]
3) Patients in whose case all the tumors were removed within 1 month before the first day of administration, and the urinary cytology following TURBT was negative for malignancy.
4) Of patients whose all tumors removed by the TURBT this time was histologically confirmed to be superficial transitional-cell cancer, those who satisfy any of the following conditions.
[Primary patients] Stage Ta or T1, G1-2
[Recurrent patients] Stage Ta or T1, G1-2 and the recurrence period between the previous TURBT and the present TURBT was 12 months or longer
5) Patients with no carry-over effects of previous treatments.
6) Patients with sufficient function of the major organs
7) Written informed consent obtained
Patient who meet one of criteria below are excluded.
1) Patients with carcinoma in situ (CIS)
2) Patients with invasive cancer of the muscle layer of the urinary bladder or a history thereof
3) Patients complicated with malignant tumors of upper urinary tract or urethra, or a history thereof
4) Patients with lymph node metastasis or metastasis in other organs
5) Patients who have received intravenous or intraarterial chemotherapy with anticancer drugs or radiotherapy for bladder carcinoma
6) Patients who have been treated with intravesical BCG
7) Patients currently on medications including steroids at immunosuppressive doses
8) Patients with congenital or acquired immunodeficiency
9) Patients with active double cancers
10) Patients with active tuberculosis or currently receiving anti-tuberculosis therapy
11) Patients with serious bacterial urinary tract infection, or a history of serious viral or bacterial infection within 4 weeks before registration
12) Patients with serious hypersensitivity or other serious complications (diseases of heart, lungs, kidneys, liver or blood)
13) Patients with a history of systemic hypersensitivity against BCG
14) Patients with a strongly positive tuberculin response
15) Patients with contracted bladder
16) Patients with interstitial pneumonia or pulmonary fibrosis
17) Pregnant, possibly pregnant or lactating women
18) Other patients assessed to be ineligible by investigator
160
1st name | |
Middle name | |
Last name | Hirotsugu Uemura, MD, PhD |
Kinki University School of Medicine
Department of Urology
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
072-366-0221
1st name | |
Middle name | |
Last name |
Kinki University School of Medicine
Department of Urology
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
072-366-0221
Kinki University School of Medicine
None
Self funding
NO
2006 | Year | 03 | Month | 24 | Day |
Unpublished
Terminated
2005 | Year | 11 | Month | 18 | Day |
2006 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2006 | Year | 03 | Month | 23 | Day |
2013 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000465