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A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy


Phase 2
N/A
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

Trial Information

A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy


OBJECTIVES:

- Estimate the safety and tolerability of induction paclitaxel, cisplatin, and
radiotherapy or fluorouracil, cisplatin, and radiotherapy followed by consolidation
chemoradiotherapy or radical cystectomy and adjuvant gemcitabine, paclitaxel, and
cisplatin in patients with operable stage II or III bladder cancer.

- Estimate the efficacy of these regimens, in terms of complete response, in patients who
have undergone prior transurethral resection (TUR).

- Estimate the efficacy of these regimens after TUR, in terms of preserving the native
tumor-free bladder 5 years after therapy, in these patients.

- Estimate the function of the preserved bladder in patients treated with these regimens
after TUR.

- Determine the value of tumor histopathologic, molecular genetic, and DNA content
parameters as possible prognostic factors for initial tumor response and
recurrence-free survival in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T
stage (T2 vs T3/T4 ). Patients are randomized to one of two treatment arms.

- Induction therapy (weeks 1-3):

- Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive
pelvic radiotherapy twice daily on days 1-5, 8-12, and 15-17.

- Arm II: Patients receive fluorouracil IV over 24 hours on days 1-3 and 15-17 and
cisplatin IV over 1 hour on days 1-3, 8-10, and 15-17. Patients also receive
pelvic radiotherapy as in arm I.

Patients in both arms who achieve complete response after induction therapy proceed to
consolidation therapy on week 8. Patients with operable pT1 or worse tumor response proceed
to radical cystectomy on week 9.

- Consolidation therapy (weeks 8 and 9):

- Arm I: Patients receive paclitaxel IV over 1 hour on days 1 and 8 and cisplatin IV
over 1 hour on days 1, 2, 8, and 9. Patients also receive pelvic radiotherapy
twice daily for 8 days.

- Arm II: Patients receive 5-FU IV over 24 hours on days 1-3 and 8-10 and cisplatin
as in arm I. Patients also receive radiotherapy as in arm I.

- Adjuvant chemotherapy (weeks 21-33 or 17-29): Beginning 12 weeks after consolidation
therapy or 8 weeks after radical cystectomy, patients receive gemcitabine IV over 30-60
minutes, paclitaxel IV over 1 hour, and cisplatin IV over 1 hour on days 1 and 8.
Treatment repeats every 3 weeks for 4 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed operable primary muscle invasive bladder cancer

- T2-T4a, NX or N0, M0 (stage II or III)

- Must have an adequate functioning bladder

- Must have undergone a prior transurethral resection of the bladder tumor within the
past 8 weeks

- No evidence of tumor-related hydronephrosis

- No evidence of distant metastases or histologically or cytologically confirmed lymph
node metastases

- Patients with involvement of the prostatic urethra with transitional cell cancer that
was visibly completely resected are allowed

- No evidence of stromal invasion of the prostate

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin at least 10 g/dL

- WBC at least 4,000/mm^3

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Serum bilirubin no greater than 2.0 mg/dL

Renal

- Serum creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater
than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion
of the study chair

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a
prostate cancer, or carcinoma in situ of the cervix

- Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical
cystectomy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior systemic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior pelvic radiotherapy

Surgery

- See Disease Characteristics

Other

- No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g.,
aminoglycosides)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completion rate

Outcome Time Frame:

Within 11 weeks of randomization

Safety Issue:

No

Principal Investigator

Anthony L. Zietman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

RTOG 0233

NCT ID:

NCT00055601

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • Urinary Bladder Neoplasms

Name

Location

LDS HospitalSalt Lake City, Utah  84143
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106