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

Uncategorized

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

Condition: Bladder Cancer, Squamous Cell Carcinoma of the Bladder, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder

Intervention:

  • Radiation: 3D conformal radiation therapy

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01954173

Sponsor: Emory University

Primary Outcome Measures:

  • 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
  • Time Frame: 3 months to 10 yrs
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Acute adverse events greater than grade 2, graded by CTCAE version 4.0
  • Time Frame: Up to 90 days
  • Safety Issue:
  • Measure: Loco-regional failure, considered any failure in the treatment field of the pelvis
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Rate of distant metastases
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Rate of disease-free survival
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Overall survival rate
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Quality of life, assessed using FACT-BL
  • Time Frame: Up to 5 years
  • Safety Issue:

Estimated Enrollment: 41

Study Start Date: July 2013

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Joseph W Shelton, MD
  • 404-616-6343

Location:

  • Emory University Hospital/Winship Cancer Institute
  • Atlanta Georgia 30322 United States

View trial on ClinicalTrials.gov

X