Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
NCT ID: NCT02671071
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
638 participants
OBSERVATIONAL
2016-04-30
2021-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Quality of Life Questionnaire (QLQ)
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cervical cancer module (EORTC QLQ-CX24) will be applied to all patients at 0, 3, 6, 12, 24, 36 months.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of FIGO stages
* Stage 1B to 2A high risk
* 2B-4B or recurrent disease
* Patients ≥18 years old
Exclusion Criteria
2. Pregnancy;
3. synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
18 Years
FEMALE
No
Sponsors
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EVA - Grupo Brasileiro de Tumores Ginecológicos
UNKNOWN
Roche Pharma AG
INDUSTRY
Latin American Cooperative Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Gustavo Werutsky, MD
Role: STUDY_DIRECTOR
Latin American Cooperative Oncology Group
Locations
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Fundação Centro de Controle do Câncer do Estado do Amazonas
Manaus, Amazonas, Brazil
CRIO
Fortaleza, Ceará, Brazil
Clínica AMO
Salvador, Estado de Bahia, Brazil
HU Walter Cantídeo
Ceará, Fortaleza, Brazil
Hospital Alderona Bello
São Luís, Maranhão, Brazil
UFMG
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
IMIP
Recife, Pernambuco, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
CPO - Hsl/Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Geral de Roraima
Boa Vista, Roraima, Brazil
CEPON
Florianópolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Litoral - Itajaí
Itajaí, Santa Catarina, Brazil
INCA
Rio de Janeiro, , Brazil
Hospital São José
São Paulo, , Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, , Brazil
Countries
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References
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Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
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.
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.
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.
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.
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.
Other Identifiers
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LACOG 0215/EVA 001
Identifier Type: -
Identifier Source: org_study_id