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A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging



- To evaluate the rate of freedom from radical cystectomy at 3 years.


- To evaluate the rate of freedom from radical cystectomy at 5 years.

- To evaluate the rate of freedom from the development of distant disease progression at
3 and 5 years.

- To evaluate the rate of freedom from progression of bladder tumor to stage T2 or
greater at 3 and 5 years.

- To evaluate disease-specific survival and overall survival.

- To evaluate the incidence of acute and late pelvic toxicity.

- To evaluate the efficacy of this treatment approach in preventing the recurrence of any
local bladder tumor.

- To evaluate the potential value of tumor histopathology plus molecular genetic, DNA
content, and urine proteomics parameters as possible significant prognostic factors for
tumor control with this treatment approach.

- To collect American Urological Association symptom scores at baseline and at 3 years.

OUTLINE: Beginning within 10 weeks of transurethral resection of the bladder tumor, patients
undergo 3-dimensional conformal radiotherapy once daily 5 days per week during weeks 1-7 (34
fractions). Patients also receive 1 of 2 radiosensitizing chemotherapy regimens concurrently
with radiotherapy.

- Regimen I: Patients receive cisplatin IV on days 1-3 of weeks 1, 3, and 5.

- Regimen II: Patients receive mitomycin C IV on day 1 of radiotherapy and fluorouracil
IV continuously over days 1-5 of weeks 1 and 4.

Patients with a persistent tumor on re-evaluation may undergo radical cystectomy.

Tissue, blood, and urine samples may be collected periodically for biomarker and other

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 3 years, and annually thereafter.

Inclusion Criteria


- Carcinoma of the bladder pathologically (histologically or cytologically) diagnosed
within the past 10 weeks, meeting either of the following criteria:

- Patients with operable tumors that are primary transitional cell carcinoma of
the bladder exhibiting histologic evidence of invasion into the lamina propria
(disease clinical stage T1) without evidence of muscularis propria invasion
(muscularis propria must be present in the transurethral resection of the
bladder tumor [TURBT] specimen) and are AJCC clinical stage T1, NX or N0, M0
without hydronephrosis

- Patients with disease involvement of the prostatic urethra with transitional
cell carcinoma and have no evidence of stromal invasion of the prostate

- No pN+ or > T1 disease

- No histologically or cytologically confirmed node metastases

- If radiologic evaluation of a lymph node is interpreted as "positive", this must
be evaluated further either by lymphadenectomy or by percutaneous needle biopsy

- No evidence of distant metastases

- Must have a T1G2 or T1G3 transitional cell carcinoma that has recurred within 18
months after initial treatment for ≤ T1 tumors (TURBT and intravesical BCG
immunotherapy) or have presented to a participating urologist who judged BCG therapy
is contraindicated because patient may be immunocompromised

- Patients for whom radical cystectomy is the standard next therapy per urologic
guidelines, in the judgement of the participating urologist, are eligible

- Must have an adequately functioning bladder as judged by the participating urologist
and radiation oncologist and have undergone a visibly complete re-staging TURBT by
the participating urologist that shows (or is present on the outside pathology
specimen) a T1G2 or T1G3 tumor with uninvolved muscularis propria in the specimen
and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no
evidence on biopsy in the prostatic stroma of tumor invasion


- Zubrod performance status 0-1

- WBC ≥ 4,000/mm^3

- ANC ≥ 1,800/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- Serum creatinine ≤ 1.5 mg/dL

- Serum bilirubin ≤ 2.0 mg/dL

- Glomerular filtration rate (GFR) > 25 mL/min (for patients receiving cisplatin, GFR >
60 mL/min)

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate systemic chemotherapy combined with radiotherapy and a radical
cystectomy (if necessary), in the opinions of the urologist, radiation oncologist,
and medical oncologist

- No prior or concurrent malignancy of any other site or histology (except for
nonmelanomatous skin cancer, T1a prostate cancer, or carcinoma in situ of the uterine
cervix) unless the patient has been disease-free for ≥ 5 years

- No severe, active co-morbidity including any of the following:

- Unstable angina and/or congestive heart failure that required hospitalization
within the past 6 months

- Transmural myocardial infarction that occurred within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics at the time of

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding any study therapy at the time of

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS based upon the current Centers for Disease Control definition (HIV testing
not required)

- No prior allergic reaction to cisplatin, mitomycin, or fluorouracil


- No prior systemic chemotherapy for bladder cancer

- Prior chemotherapy for a different cancer allowed

- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields

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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of freedom from radical cystectomy at 3 years

Safety Issue:


Principal Investigator

William U. Shipley, MD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital



Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms



University of Texas Medical Branch Galveston, Texas  77555-1329
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Beth Israel Medical Center - Petrie Division New York, New York  10003-3803
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Cancer Treatment Center Wooster, Ohio  44691
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Cancer Care Center, Incorporated Salem, Ohio  44460
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Emory Crawford Long Hospital Atlanta, Georgia  30308
St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Norris Cotton Cancer Center - North Saint Johnsbury, Vermont  05819