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Adjuvant Radiation for High Risk Bladder Cancer

Primary Purpose

Bladder Cancer, Squamous Cell Carcinoma of the Bladder, Stage III Bladder Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

3D conformal radiation therapy

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University Hospital/Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D conformal radiation therapy

Arm Description

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.

Outcomes

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

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

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

The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.

Rate of distant metastases

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

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

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

Full Information

NCT ID

NCT01954173

First Posted

August 19, 2013

Last Updated

February 14, 2022

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT01954173

Brief Title

Adjuvant Radiation for High Risk Bladder Cancer

Official Title

Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

July 22, 2013 (Actual)

Primary Completion Date

September 20, 2021 (Actual)

Study Completion Date

September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3D conformal radiation therapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

3D conformal radiation therapy

Other Intervention Name(s)

3D-CRT, IMRT, Intensity Modulated Radiotherapy

Intervention Description

Undergo conformal radiation therapy

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 months to 10 yrs

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 90 days

Title

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

Description

The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.

Time Frame

Up to 5 years

Title

Rate of distant metastases

Description

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.

Time Frame

Up to 5 years

Title

Rate of disease-free survival

Description

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.

Time Frame

Up to 5 years

Title

Overall survival rate

Description

Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival.

Time Frame

Up to 5 years

Title

Quality of life, assessed using FACT-BL

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph W Shelton, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

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Adjuvant Radiation for High Risk Bladder Cancer

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