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Brief Title: Adjuvant Radiation for High Risk Bladder Cancer

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

INTRODUCTION

  • Org Study ID: IRB00059097
  • Secondary ID: NCI-2013-01381, RAD2271-12
  • NTC ID: NCT01954173
  • Sponsor: 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


PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

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
[LND]).

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).

OUTLINE:

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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    N/A
  • Study Type
    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 - Timeframe: 3 months to 10 yrs

CONDITION

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

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

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

Email: jwshelt@emory.edu

LOCATION

Facility Status Contact
Facility: Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States 		Status: Recruiting Contact:
Joseph W Shelton, MD
404-616-6343
jwshelt@emory.edu

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