Radiation Therapy After Surgery in Treating Patients With High-Risk Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Joseph W Shelton MD, Emory University
ClinicalTrials.gov Identifier:
NCT01954173
First received: August 19, 2013
Last updated: September 26, 2014
Last verified: September 2014
  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.


Condition Intervention Phase
Bladder Cancer
Squamous Cell Carcinoma of the Bladder
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Radiation: 3-dimensional conformal radiation therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Adjuvant Conformal Radiotherapy in High Risk Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Acute adverse events greater than grade 2, graded by CTCAE version 4.0 [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
  • Loco-regional failure, considered any failure in the treatment field of the pelvis [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: July 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy)
Within 12 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: 3-dimensional conformal radiation therapy
Undergo conformal radiation therapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
  • IMRT
  • Intensity Modulated Radiotherapy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Procedure: therapeutic conventional surgery
Undergo surgical resection

Detailed Description:

PRIMARY OBJECTIVES:

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 12 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 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954173

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Joseph W. Shelton    404-616-6343    jwshelt@emory.edu   
Principal Investigator: Joseph W. Shelton         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Joseph Shelton Emory University
  More Information

No publications provided

Responsible Party: Joseph W Shelton MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01954173     History of Changes
Other Study ID Numbers: IRB00059097, NCI-2013-01381, RAD2271-12
Study First Received: August 19, 2013
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 16, 2014