Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database

The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.

Study Overview

• Status: Completed
• Conditions: Recurrent/Metastatic Urothelial Cancers

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil
      • CLION
    • Salvador, BA, Brazil
      • Clinica AMO
    • Salvador, BA, Brazil
      • Hospital Sao Rafael
  • PR
    • Curitiba, PR, Brazil
      • LIGA
  • RS
    • Porto Alegre, RS, Brazil
      • CPO Pucrs
  • SC
    • Florianópolis, SC, Brazil
      • CEPON
  • SP
    • São Paulo, SP, Brazil
      • Beneficência Portuguesa
    • São Paulo, SP, Brazil
      • Centro Paulista de Oncologia
    • São Paulo, SP, Brazil
      • Sírio Libanês

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.

Description

Inclusion Criteria:

1. Age at least 18 years;
2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

Exclusion Criteria:

1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
2. Pure non-urothelial carcinoma histology.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiology	Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socioeconomic chactacteristcs	Health Care Insurance (Public or Private)	2 years
Overall response	Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1	2 years
Duration of response	Defined as the time from response to progression by RECIST v11.1 or death	2 years
PFS	Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line.	2 years

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Janssen-Cilag Ltd.
• Investigators: Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• 1. Milowsky MI, Rumble RB, Booth CM, et al. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016;34(16):1945-1952. doi:10.1200/JCO.2015.65.9797 2. Instituto Nacional de Câncer José Alencar Gomes. Estimativa 2018: Incidência de Câncer No Brasil. Rio de Janeiro: INCA; 2018. http://www.inca.gov.br/estimativa/2018. 3. International Agency for Research on Cancer, International Association of Cancer Registries. Cancer Incidence in Five Continents. Volume X Volume X.; 2014. http://www.iarc.fr/en/publications/pdfs-online/epi/sp164/. Accessed November 21, 2018. 4. Secretaria de Estado da Saúde de São Paulo. FOSP - Fundação Oncocentro de São Paulo. http://www.fosp.saude.sp.gov.br/. Accessed October 30, 2018. 5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-1259. doi:10.1016/S0140-6736(00)02799-9

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: metastatic; bladder; urethra; recurrent; ureter; renal pelvis; urothelial cancers
• Other Study ID Numbers: LACOG 1518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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