Adjuvant Radiation for High Risk Bladder Cancer

• ClinicalTrials.gov Identifier: NCT01954173
• Recruitment Status: Terminated
• First Posted: October 1, 2013
• Last Update Posted: March 2, 2022
• Sponsor: Emory University
• Information provided by (Responsible Party): Joseph W Shelton MD, Emory University

Tracking Information

• First Submitted Date: August 19, 2013
• First Posted Date: October 1, 2013
• Last Update Posted Date: March 2, 2022
• Actual Study Start Date: July 22, 2013
• Actual Primary Completion Date: September 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2013)

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 ]

For purposes of this study, "bowel adverse events" are defined as the following: diarrhea, enteritis, fistula, ileus, incontinence, obstruction, perforation, proctitis, and stricture/stenosis (including anastomotic) as graded buy Common Terminology for Adverse Events (CTCAE) version 4.0.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 26, 2013)

• Acute adverse events greater than grade 2, graded by CTCAE version 4.0 [ Time Frame: Up to 90 days ]
• Loco-regional failure, considered any failure in the treatment field of the pelvis [ Time Frame: Up to 5 years ]
  The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.
• Rate of distant metastases [ Time Frame: Up to 5 years ]
  Nodal disease beyond the common iliac will be considered distant failure. The cumulative incidence approach will be used to estimate the failure rate for distant failure.
• Rate of disease-free survival [ Time Frame: Up to 5 years ]
  Any tumor recurrence, development of distant metastases or death is considered a failure. The Kaplan-Meier method will be used to estimate the disease-free survival rate.
• Overall survival rate [ Time Frame: Up to 5 years ]
  Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival.
• Quality of life, assessed using FACT-BL [ Time Frame: Up to 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjuvant Radiation for High Risk Bladder Cancer
• Official Title: Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

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

Undergo conformal radiation therapy

Other Names:

• 3D-CRT
• IMRT
• Intensity Modulated Radiotherapy

Study Arms

Experimental: 3D conformal radiation therapy

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

Intervention: Radiation: 3D conformal radiation therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 22, 2021): 19
• Original Estimated Enrollment (submitted: September 26, 2013): 41
• Actual Study Completion Date: September 20, 2021
• Actual Primary Completion Date: September 20, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01954173
• Other Study ID Numbers: IRB00059097; NCI-2013-01381 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); RAD2271-12 ( Other Identifier: Emory University )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joseph W Shelton MD, Emory University
• Original Responsible Party: Same as current
• Current Study Sponsor: Emory University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph W Shelton, MD; Emory University

• PRS Account: Emory University
• Verification Date: February 2022