Adjuvant Radiation for High Risk Bladder Cancer

NCT ID: NCT01954173

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-22
• Study Completion Date: 2021-09-20

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

3D conformal radiation therapy

Intervention Type: RADIATION

Undergo conformal radiation therapy

Interventions

3D conformal radiation therapy

Undergo conformal radiation therapy

Intervention Type: RADIATION

Other Intervention Names

3D-CRT; IMRT; Intensity Modulated Radiotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Joseph W Shelton MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph W Shelton, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

NCI-2013-01381

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD2271-12

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00059097

Identifier Type: -

Identifier Source: org_study_id