Clinical trial NCT02671071: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Official title: Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Cancer
Keywords: Cervix Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: EVA - Grupo Brasileiro de Tumores Ginecológicos
name: Roche Pharma AG
First posted: 2016-02-02
Enrollment: 638
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cervical cancer in 1-year period (recently diagnosed IB to IIA high risk or IIB-IVB or recurrent disease - FIGO stages) at the participating sites will be included in the study.

Brief summary: The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with CC in Brazil.

Detailed description: The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with cervix cancer (CC) in Brazil. Other specific objectives are:

* To describe socio-demographic characteristics: age at diagnosis, education, family income, race, occupation, personal health habits - e.g.oral contraceptive use ever/never and duration; smoking never/ever/current/duration , ever drinking), sexual history, insurance coverage (private, public), institution (private, public, philanthropic), obstetric history, comorbidities, performance status, human papillomavirus vaccination or not
* To describe the screening for CC: access, type, frequency and results.
* To describe clinical pathological characteristics of CC: histology (adeno x squamous x adenosquamous x neuroendocrine x other) , International Federation of Gynecology and Obstetrics (FIGO) stage, pathological stage, exams for staging, date of diagnosis, site of metastasis.
* To describe treatment characteristics of CC: date of surgery, type of surgery; date and duration of radiotherapy, type of radiotherapy; date, type and lines of systemic therapy (chemotherapy, monoclonal antibodies),
* To describe treatment safety (grade 3-4 AEs, death due to treatment toxicity, discontinuation due to AE). In addition adverse events of special interest will be described (details on Safety section).
* To describe the outcomes: follow-up exams and date of visits, persistent disease, recurrence, progression times in metastatic disease, complications (e.g. hydronephrosis/nephrostomy/ GI perforations and both GI \& genitourinary fistulae.), death due CC and death from any cause.

Eligibility criteria: Inclusion Criteria:

* Histologic confirmed invasive cervical cancer
* Diagnosis of FIGO stages
* Stage 1B to 2A high risk
* 2B-4B or recurrent disease
* Patients ≥18 years old

Exclusion Criteria:

1. Non-invasive uterine carcinoma;
2. Pregnancy;
3. synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).

Primary outcomes:
measure: Characterization of cervix cancer in the Brazilian female population
timeFrame: 3 years
Secondary outcomes:
measure: Socio-demographic characteristics of the female population diagnosed with CC
timeFrame: Month 0 (beginning of the study)
measure: Description of the method used to diagnose the brazillian female patients with cervix cancer
timeFrame: Month 0
measure: The clinical and pathological characteristics of cervix cancer in brazilian female patients
timeFrame: Month 0
measure: Type of treatment assessed in patients with CC
timeFrame: Month 0, 3, 6,12, 24 and 36
measure: Number of patients with disease survival
timeFrame: Month 3, 6, 12, 24 and 36
measure: Number of patients with progression survival
timeFrame: Month 3, 6, 12, 24 and 36
measure: Number of patients with overall survival
timeFrame: Month 3, 6, 12, 24 and 36
measure: Number of patients with disease overall survival
timeFrame: Month 3, 6, 12, 24 and 36
measure: Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients
timeFrame: Month 0, 3, 6,12, 24 and 36
measure: Duration of treatment after the diagnosis of cervix cancer
timeFrame: Month 0, 3, 6,12, 24 and 36
measure: Description of adverse effects of the cervix cancer treatment
timeFrame: Month 0, 3, 6,12, 24 and 36
measure: Number of adverse effects of the cervix cancer treatment
timeFrame: Month 0, 3, 6,12, 24 and 36
measure: Type of clinical outcomes of the patients with cervix cancer in Brazil
timeFrame: Month 0, 3, 6,12, 24 and 36
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Fundação Centro de Controle do Câncer do Estado do Amazonas
state: Amazonas
city: Salvador
country: Brazil
facility: Clínica AMO
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO
state: Ceará
city: Ceara
country: Brazil
facility: HU Walter Cantídeo
state: Fortaleza
city: Sao Luis
country: Brazil
facility: Hospital Alderona Bello
state: Maranhão
city: Belo Horizonte
country: Brazil
facility: UFMG
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Hsl/Pucrs
state: Rio Grande Do Sul
city: Boa Vista
country: Brazil
facility: Hospital Geral de Roraima
state: Roraima
city: Florianopolis
country: Brazil
facility: CEPON
state: Santa Catarina
city: Itajaí
country: Brazil
facility: Centro de Novos Tratamentos Litoral - Itajaí
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: INCA
city: Sao Paulo
country: Brazil
facility: Hospital São José
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Câncer - IBCC
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
References:
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citation: Munoz N, Franco EL, Herrero R, Andrus JK, de Quadros C, Goldie SJ, Bosch FX. Recommendations for cervical cancer prevention in Latin America and the Caribbean. Vaccine. 2008 Aug 19;26 Suppl 11:L96-L107. doi: 10.1016/j.vaccine.2008.05.062.
citation: Hellner K, Munger K. Human papillomaviruses as therapeutic targets in human cancer. J Clin Oncol. 2011 May 1;29(13):1785-94. doi: 10.1200/JCO.2010.28.2186. Epub 2011 Jan 10.
citation: Martinez-Mesa J, Werutsky G, Campani RB, Wehrmeister FC, Barrios CH. Inequalities in Pap smear screening for cervical cancer in Brazil. Prev Med. 2013 Oct;57(4):366-71. doi: 10.1016/j.ypmed.2013.06.026. Epub 2013 Jul 1.
citation: Zuliani AC, Esteves SC, Teixeira LC, Teixeira JC, de Souza GA, Sarian LO. Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial. J Clin Oncol. 2014 Feb 20;32(6):542-7. doi: 10.1200/JCO.2013.50.1205. Epub 2014 Jan 21.
citation: Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. doi: 10.1200/JCO.2002.20.4.966.