- Demonstrate that after complete transurethral resection of all papillary tumors, one third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose BCG and short term maintenance is equivalent to long term maintenance with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up.
- Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects.
Entry Criteria
Disease Characteristics:
- Histologically confirmed transitional cell carcinoma of the bladder of the following types:
- Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3
- Solitary T1 GIII tumor
Prior/Concurrent Therapy:
Biologic therapy:
- No prior treatment with BCG
Chemotherapy:
- No cytostatic agents within the past 3 months
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics:
Age:
Performance status:
Life expectancy:
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Values used to evaluate function may not exceed two times the upper limit of normal
Renal:
- Values used to evaluate function may not exceed two times the upper limit of normal
Other:
- No second malignancy except basal cell skin carcinoma
- Not pregnant or nursing
- No uncontrollable urinary tract infection
- No active tuberculosis
- No HIV antibody
- No leukemia
- No Hodgkin's disease
- No transplant recipients
Expected Enrollment 1288
1288 patients will be accrued for this study.
Outcomes Primary Outcome(s)
Dose equivalency with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up
Dose equivalency in terms of fewer local and systemic side effects
Outline
This is a prospective randomized study.
At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens:
- Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
- Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
- Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30 and 36.
- Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30, and 36.
The patient is followed every 3 months for the first 3 years, and every 6 months thereafter.
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
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| A. Van Der Meijden, MD, PhD, Study coordinator(Contact information may not be current) |
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ONCOTICE LP.INVES.L 2-8x100.000.000MG CFU (12.5+3.0)MG/VIAL BT 1VIAL
疾病特征：
组织学证实为移行细胞癌，膀胱以下几种类型：
多个（不大于10），可切除，T1或Ta，G1-G3级
孤T1 GIII肿瘤
之前/同时治疗：
生物疗法：
事先没有与BCG治疗
化疗：
在过去3个月内无细胞生长抑制剂
内分泌治疗：
未指定
放射治疗：
未指定
手术治疗：
未指定
病人的特点：
年龄：
85及以下
治疗方案概述
这是一项前瞻性随机对照研究。
在经尿道前列腺切除后7-15天，患者开始接受以下四个方案：
方案1：第三剂量卡介苗（BCG）疫苗加短期的维护。患者接受一个第三剂BCG注入了每周一次，共6周，随后由每周三班灌注在个月内3，6，和12。
方案2：全剂量卡介苗加短期的维护。患者接受全剂量的卡介苗注入了为期6周，每周一次，由每周三班灌注3，6，和12个月时。
方案3：第三次接种卡介苗加长期维护。患者接受的三分之一，每周一次，6个月内3，6，12，18，24，30和36周，随后由每周三班灌注BCG灌注剂量。
方案4：全剂量卡介苗加长期维护。患者接受全剂量的卡介苗注入了每周一次的6个月内3，6，12，18，24，30，和36周，随后由每周三班灌注。
病人每3个月的第3年，此后每6个月。 |
