Adjuvant Radiation for High Risk Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT01954173|
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
I. Determine the feasibility of adjuvant radiation in the management of high-risk disease.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2030|
|Estimated Study Completion Date :||July 2030|
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
- 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.
- 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 ]
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
|Contact: Joseph W Shelton, MDfirstname.lastname@example.org|
|Contact: Giesla Rodgersemail@example.com|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Joseph W Shelton, MD 404-616-6343 firstname.lastname@example.org|
|Principal Investigator: Joseph W Shelton, MD|
|Principal Investigator:||Joseph W Shelton, MD||Emory University|