Adjuvant Radiation for High Risk Bladder Cancer

NCT01954173 | Terminated DMC

• 3 other identifiers: IRB00059097NCI-2013-01381RAD2271-12
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales

  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.

  3 months to 10 yrs

Secondary Outcomes (6)

• Acute adverse events greater than grade 2, graded by CTCAE version 4.0

  Up to 90 days

• Loco-regional failure, considered any failure in the treatment field of the pelvis

  Up to 5 years

• Rate of distant metastases

  Up to 5 years

• Rate of disease-free survival

  Up to 5 years

• Overall survival rate

  Up to 5 years

Study Arms (1)

3D conformal radiation therapy

EXPERIMENTAL

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.

Radiation: 3D conformal radiation therapy

Interventions

3D conformal radiation therapy RADIATION

Undergo conformal radiation therapy

Also known as: 3D-CRT, IMRT, Intensity Modulated Radiotherapy

3D conformal radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Joseph W Shelton, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: October 1, 2013
• Study Start: July 22, 2013
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)