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BRIEF TITLE: Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

  • Org Study ID: IRB00059097
  • Secondary ID: NCI-2013-01381,RAD2271-12
  • NCT ID: NCT01954173
  • NCT Alias:
  • Sponsor: Emory University - Other
  • Source: Emory University

Brief Summary

This phase II trial studies how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. 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.

Detailed Description


I. Determine the feasibility of adjuvant radiation in the management of high-risk disease.


I. Prospectively evaluate patterns of failure in high-risk bladder cancer patients after
cystectomy and aggressive adjuvant therapy.

II. Define surgical and histopathologic parameters predictive of local and distant outcomes
(e.g. grade, lymphovascular space invasion [LVSI], extent of resection/lymph node dissection

III. Assess quality of life (QoL) outcomes after this treatment using a standardized
questionnaires (Functional Assessment of Cancer Therapy-General [FACT-G], FACT-Bladder Cancer
[BL], Expanded Prostate Cancer Index Composite [EPIC] Bowel and Urinary).


Within 24 weeks of surgical resection, patients undergo 3D conformal radiation therapy once
daily 5 days per week for 28 fractions. Treatment continues in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for
2 years, every 6 months for 3-5 years, and then annually thereafter.

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 2013 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales

Primary Outcome 1 - Time Frame: 3 months to 10 yrs


  • Bladder Cancer
  • Squamous Cell Carcinoma of the Bladder
  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder


Inclusion Criteria:

- Pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder

- Patients must have undergone cystectomy (total cystectomy, radical cystectomy +/-
pelvic lymph node dissection) with no evidence of macroscopic residual disease

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2

- Patients treated with simple cystectomy with macroscopically negative margins are
eligible for this study

- Clinical T-stage (prior to systemic therapy, if applicable) ≥ T3a and/or positive
lymph nodes by transurethral resection of bladder tumor (TURBT)/magnetic resonance
imaging (MRI)/computed tomography (CT)/positron emission tomography (PET)-CT or
pathologic T-stage ≥ T3a and/or positive lymph nodes

Exclusion Criteria:

- Patients with metastatic disease outside of the pelvis

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years

- Prior radiation therapy to the pelvis

- Patients with active inflammatory bowel disease

- Severe acute co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization in the
last 3 months

- Transmural myocardial infarction within the last 6 months

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

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

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this
protocol; the need to exclude patients with AIDS from this protocol is necessary
because the treatment involved in this protocol may be significantly
immunosuppressive; protocol-specific requirements may also exclude
immunocompromised patients
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Joseph W Shelton, MD

Role: Principal Investigator

Affiliation: Emory University

Overall Contact

Name: Joseph W Shelton, MD

Phone: 404-616-6343



Facility Status Contact
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Recruiting Joseph W Shelton, MD