Trimodality Treatment in Bladder Cancer

Retrospective Study Protocol on Bladder Cancer With Bladder Preservation Intent

Bladder cancer is a malignant disease that affects a large number of people worldwide. An increase in the incidence of this type of cancer has been observed in recent decades, leading to a growing interest in understanding its risk factors, clinical evolution, and possible treatment approaches. This retrospective study aims to retrospectively analyze a cohort of patients diagnosed with muscle-invasive bladder cancer, in whom, after presentation at multidisciplinary oncology committees, the goal of curing the oncological disease while preserving the bladder is considered.

Trimodal therapy (TMT) is the most studied bladder preservation strategy, with oncological outcomes superior to those of isolated therapies (or monotherapies) such as transurethral resection of the bladder tumor (TURBT), radiotherapy, or chemotherapy. TMT consists of complete and maximal TURBT of the bladder tumor, followed by definitive radiotherapy combined with a radiosensitizing agent.

Objectives The main objective is to retrospectively analyze the effectiveness and safety of the trimodal approach in our setting. Collecting and analyzing data from patients treated in our service will provide valuable insight into clinical outcomes and treatment tolerability in this context.

Materials and Methods

• Study Design A retrospective study will be conducted using data from medical records of patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected.
• Study Population The study population will include all patients with confirmed diagnoses of non-metastatic muscle-invasive bladder cancer.

Study Overview

• Status: Recruiting
• Conditions: Urinary Bladder Neoplasms; Bladder Cancer; Bladder Disease
• Intervention / Treatment: Radiation: radioteraphy and chemotherapy after RTU --trimodality therapy--

Detailed Description

• Inclusion Criteria Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.

Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.

-Functional and compatible bladder at the start of the study.

Criteria related to the tumor:

• cT2
• Unifocal tumor with a maximum diameter < 7 cm.
• Single tumor.
• Absence of extensive associated carcinoma in situ (CIS).
• Absence of bilateral hydronephrosis.
• Absence of lymphovascular invasion.
• Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).

Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

• Data Collection Data will be retrospectively collected from patients' electronic medical records. Standardized forms will be used to record relevant data, including demographic information, medical history, imaging study results, treatment details, and follow-up.
• Statistical Analysis Descriptive analysis of the data will be performed to summarize the characteristics of the study population and clinical outcomes. Appropriate statistical tests will be used to compare patient subgroups and assess the association between variables of interest and clinical outcomes.
• Ethical Considerations This study will be conducted following the ethical principles established in the Helsinki Declaration. Approval will be obtained from our hospital's Ethics Committee.
• Study Limitations Potential limitations of this study may include inherent bias in retrospective studies, incomplete data in some medical records, and variability in treatments administered over time.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Nicolas Feltes Benitez, MD; Phone Number: 937003690; Email: nicofeltes_81@hotmail.com
• Study Contact Backup: Name: Saturio Paredes Rubio, MD; Phone Number: 937003690; Email: sparedes@cst.cat

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08225
      • Recruiting
      • Hospital de Terrassa
      • Sub-Investigator: SATURIO PAREDES
      • Contact: nicolas feltes; Phone Number: 937003690; Email: nicofeltes_81@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with bladder cancer from 2014 to 2022 and treated with radiotherapy in our Radiation Oncology Service. Demographic data, medical history, risk factors, clinical characteristics, treatments received, and clinical outcomes will be collected

Description

Inclusion Criteria:

• Adult patients (over 18 years old) with histologically confirmed diagnosis of bladder cancer.

Criteria for selecting optimal candidates for trimodal therapy-assessment in Uro-Oncology committees.

-Functional and compatible bladder at the start of the study.

Criteria related to the tumor:

• cT2
• Unifocal tumor with a maximum diameter < 7 cm.
• Single tumor.
• Absence of extensive associated carcinoma in situ (CIS).
• Absence of bilateral hydronephrosis.
• Absence of lymphovascular invasion.
• Attempt at macroscopically complete TURBT of the bladder (incomplete does not exclude bladder preservation).

Availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

Exclusion Criteria:

• Not availability of complete medical records, including demographic data, medical history, imaging study results, treatment details, and follow-up.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control	Local Control assessed by RECIST criteria with TC, MRI or PET-scan	5-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Defined as the time from diagnose to the date of death from any cause.	Overall Survival [ Time Frame: Participants should be followed continuously during 5-10 years Defined as the time from diagnose to the date of death from any cause.

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Estimated): June 2, 2024
• Study Completion (Estimated): June 2, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Estimated): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Urinary Bladder Diseases
• Other Study ID Numbers: TRIMODAL-VEJIGA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No