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Adjuvant Radiation for High Risk Bladder Cancer

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Emory University

Status

Terminated

Conditions

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

Treatments

Radiation: 3D conformal radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01954173
RAD2271-12 (Other Identifier)
NCI-2013-01381 (Registry Identifier)
IRB00059097

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

3D conformal radiation therapy
Experimental group
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.
Treatment:
Radiation: 3D conformal radiation therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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