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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

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Trial Conditions
  • Bladder Cancer
What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.

Date & Status


Who can Participate?


18  - 120 




- Pathologically (histologically or cytologically) diagnosis of carcinoma of the
bladder within 105 days prior to registration.

- Patients with operable tumors that are primary high grade urothelial carcinoma
of the bladder exhibiting histologic evidence of invasion into the lamina
propria (disease clinical stage T1) or a high grade stage Ta urothelial
carcinoma without hydronephrosis.

- Patients with disease involvement of the prostatic urethra with urothelial
carcinoma and have no evidence of stromal invasion of the prostate. If the
patient's initial tumor was a high grade Ta urothelial carcinoma then his/her
recurrent tumor must be a high grade stage T1 urothelial carcinoma to be

- Patients must have a high grade urothelial carcinoma stage Ta or T1 that has
recurred within 540 days after completion of the initial treatment
(transurethral resection bladder tumor [TURBT] and intravesical bacillus
Calmette-Guerin [BCG] immunotherapy) or have presented to a participating
urologist who judged BCG therapy is contraindicated because this patient may be
immuno-compromised or because the patients refuses BCG therapy

- No confirmed tumor-related hydronephrosis

- 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

- 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

- White blood cell count (WBC) ≥ 4,000/mm^3

- Absolute neutrophil count (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 5-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.,

Gender: Both
Steward Physician(s)
  • William U. Shipley, MD, FACR
  • Saint Anne's Hospital - Recruiting
Trial Interventions
  • cisplatin
  • fluorouracil
  • mitomycin C
For more information about this trial, contact

Clinical Trials Office - Hudner Oncology Center at Saint Anne'

Phone: (508) 674-5600

Physician Researcher

Investigator Name:

  • William U. Shipley, MD, FACR

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00981656
Volunteers:  Not Accepting Healthy Volunteers

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