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BRIEF TITLE: Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging

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


  • Org Study ID: RTOG 0926
  • Secondary ID: CDR0000654727
  • NCT ID: NCT00981656
  • NCT Alias:
  • Sponsor: Radiation Therapy Oncology Group - Other
  • Source: Radiation Therapy Oncology Group

Brief Summary

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.

Detailed Description


OBJECTIVES:

Primary

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

Secondary

- 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
analysis.

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.

Overal Status Start Date Phase Study Type
Recruiting November 2009 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Rate of freedom from radical cystectomy at 3 years

Primary Outcome 1 - Time Frame: Three years from the date of registration.

Condition:

  • Bladder Cancer

Eligibility

Criteria:
DISEASE CHARACTERISTICS:

- 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
eligible.

- 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

PATIENT CHARACTERISTICS:

- 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
registration

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

- 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

PRIOR CONCURRENT THERAPY:

- 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.,
aminoglycoside)
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Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

Official Information

Name: William U. Shipley, MD, FACR

Role: Principal Investigator

Affiliation: Massachusetts General Hospital

Locations

Facility Status Contact
Emory Crawford Long Hospital
Atlanta, Georgia 30308
United States
Recruiting Peter J. Rossi
404-686-4411
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Recruiting Clinical Trials Office - Winship Cancer Institute
404-778-1900
St. Agnes Hospital Cancer Center
Baltimore, Maryland 21229
United States
Recruiting Richard S. Hudes, MD
410-368-2965
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts 02721
United States
Recruiting Clinical Trials Office - Hudner Oncology Center at Saint Anne'
508-674-5600
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756-0002
United States
Recruiting Clinical Trials Office - Norris Cotton Cancer Center
603-650-7609
cancerhelp@dartmouth.edu
Beth Israel Medical Center - Petrie Division
New York, New York 10003-3803
United States
Recruiting Clinical Trials Office - Beth Israel Medical Center - Petrie D
212-844-6286
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio 44309-2090
United States
Recruiting Clinical Trials Office - Akron City Hospital
330-375-6101
Barberton Citizens Hospital
Barberton, Ohio 44203
United States
Recruiting William F. Demas, MD
330-375-3557
Cancer Care Center, Incorporated
Salem, Ohio 44460
United States
Recruiting William F. Demas, MD
330-375-3557
Cancer Treatment Center
Wooster, Ohio 44691
United States
Recruiting Clinical Trials Office - Cancer Treatment Center
330-375-4221
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania 19111-2497
United States
Recruiting Clinical Trials Office - Fox Chase Cancer Center - Philadelphi
215-728-4790
University of Texas Medical Branch
Galveston, Texas 77555-0361
United States
Recruiting Clinical Trials Office - University of Texas Medical Branch
409-772-1950
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont 05819
United States
Recruiting Alan C. Hartford, MD, PhD
603-650-6600