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A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder


Phase 2
N/A
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder


OBJECTIVES:

- Compare the complete response rate of patients with carcinoma in situ of the bladder
treated with adjuvant intravesical BCG with or without intravesical mitomycin following
transurethral resection.

- Compare the disease-free interval and type of recurrence after complete response in
patients treated with these regimens.

- Compare the side effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one
of two treatment arms.

Arm I:

- Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on
weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions
or disease recurrence or progression undergo transurethral resection (TUR) during weeks
16-18 and receive one additional course of intravesical therapy.

- Maintenance therapy:Patients with a complete response after either course of induction
therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1
and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6
months through year 3.

Arm II:

- Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12.
Patients with visible lesions or disease recurrence or progression undergo
transurethral resection (TUR) during weeks 16-18 and receive one additional course of
intravesical therapy.

- Maintenance therapy: Patients with a complete response after either course of induction
therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks
1-3. Maintenance therapy repeats every 6 months through year 3.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for
this study within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology

- Primary CIS (no prior history of CIS, papillary, or solid transitional cell
carcinoma [TCC] of the bladder and no concurrent papillary or solid TCC) OR

- Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the
bladder) OR

- Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of
the bladder)

- No more than 28 days since prior transurethral resection (TUR) of all visible lesions

- No muscle involvement

- No prior or concurrent upper urinary tract tumors

- No urethral strictures that would prevent endoscopic procedures and repeated
catheterization

- No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that
would make multiple transurethral procedures risky

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- No active tuberculosis (highly positive skin tests allowed if no active disease)

- No disease that would preclude general anesthesia

- No active intractable or uncontrollable infection

- No other prior or concurrent malignancy except cured basal cell skin cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior BCG

Chemotherapy:

- More than 3 months since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the pelvis

Surgery:

- See Disease Characteristics

Other:

- More than 3 months since prior intravesical cytostatic agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Aldo V. Bono, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale di Circolo e Fondazione Macchi

Authority:

United States: Federal Government

Study ID:

EORTC-30993

NCT ID:

NCT00023842

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma in Situ

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