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Adjuvant Radiation for High Risk Bladder Cancer

This study is currently recruiting participants.
Verified March 2017 by Joseph W Shelton MD, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954173
First Posted: October 1, 2013
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph W Shelton MD, Emory University
  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
Bladder Cancer Squamous Cell Carcinoma of the Bladder Stage III Bladder Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Radiation: 3D conformal radiation therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Joseph W Shelton MD, 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 ]
    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 ]
  • 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 ]

Estimated Enrollment: 41
Study Start Date: July 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: 3D conformal radiation therapy
Undergo conformal radiation therapy
Other Names:
  • 3D-CRT
  • IMRT
  • Intensity Modulated Radiotherapy

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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954173


Contacts
Contact: Joseph W. Shelton, MD 404-616-6343 jwshelt@emory.edu
Contact: Giesla Rodgers 404-778-5162 grodg01@emory.edu

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

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD2271-12 ( Other Identifier: Emory University )
First Submitted: August 19, 2013
First Posted: October 1, 2013
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Squamous Cell
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