Clinical trial NCT01954173: Adjuvant Radiation for High Risk Bladder Cancer
Official title: Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Squamous Cell Carcinoma of the Bladder
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 3 months to 10 yrs
Secondary outcomes:
measure: Acute adverse events greater than grade 2, graded by CTCAE version 4.0
timeFrame: Up to 90 days
measure: Loco-regional failure, considered any failure in the treatment field of the pelvis
timeFrame: Up to 5 years
measure: Rate of distant metastases
timeFrame: Up to 5 years
measure: Rate of disease-free survival
timeFrame: Up to 5 years
measure: Overall survival rate
timeFrame: Up to 5 years
measure: Quality of life, assessed using FACT-BL
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Joseph W Shelton, MD
role: PRINCIPAL_INVESTIGATOR
References: