Donate
Back to Clinical Trials
Back to Clinical Trials

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: N/A
  • NCT 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
    Terminated
  • Start Date
    July 22, 2013
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: 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: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

Read Our Stories