Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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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
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To describe the screening for CC: access, type, frequency and results.
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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.
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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),
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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).
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Characterization of cervix cancer in the Brazilian female population [3 years]
Secondary Outcome Measures
- Socio-demographic characteristics of the female population diagnosed with CC [Month 0 (beginning of the study)]
- Description of the method used to diagnose the brazillian female patients with cervix cancer [Month 0]
Screening tests (Papanicolaou test) or symptoms presented by patients
- The clinical and pathological characteristics of cervix cancer in brazilian female patients [Month 0]
- Type of treatment assessed in patients with CC [Month 0, 3, 6,12, 24 and 36]
Radiotherapy, Chemotherapy and/or Surgery
- Number of patients with disease survival [Month 3, 6, 12, 24 and 36]
- Number of patients with progression survival [Month 3, 6, 12, 24 and 36]
- Number of patients with overall survival [Month 3, 6, 12, 24 and 36]
- Number of patients with disease overall survival [Month 3, 6, 12, 24 and 36]
- Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients [Month 0, 3, 6,12, 24 and 36]
- Duration of treatment after the diagnosis of cervix cancer [Month 0, 3, 6,12, 24 and 36]
- Description of adverse effects of the cervix cancer treatment [Month 0, 3, 6,12, 24 and 36]
- Number of adverse effects of the cervix cancer treatment [Month 0, 3, 6,12, 24 and 36]
- Type of clinical outcomes of the patients with cervix cancer in Brazil [Month 0, 3, 6,12, 24 and 36]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologic confirmed invasive cervical cancer
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Diagnosis of FIGO stages
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Stage 1B to 2A high risk
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2B-4B or recurrent disease
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Patients ≥18 years old
Exclusion Criteria:
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Non-invasive uterine carcinoma;
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Pregnancy;
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synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fundação Centro de Controle do Câncer do Estado do Amazonas | Manaus | Amazonas | Brazil | |
| 2 | Clínica AMO | Salvador | Bahia | Brazil | |
| 3 | CRIO | Fortaleza | Ceará | Brazil | |
| 4 | HU Walter Cantídeo | Ceara | Fortaleza | Brazil | CE |
| 5 | Hospital Alderona Bello | Sao Luis | Maranhão | Brazil | |
| 6 | UFMG | Belo Horizonte | Minas Gerais | Brazil | |
| 7 | Hospital Erasto Gaertner | Curitiba | Paraná | Brazil | |
| 8 | IMIP | Recife | Pernambuco | Brazil | |
| 9 | Hospital São Vicente de Paulo | Passo Fundo | Rio Grande Do Sul | Brazil | |
| 10 | CPO - Hsl/Pucrs | Porto Alegre | Rio Grande Do Sul | Brazil | |
| 11 | Hospital Geral de Roraima | Boa Vista | Roraima | Brazil | |
| 12 | CEPON | Florianopolis | Santa Catarina | Brazil | |
| 13 | Centro de Novos Tratamentos Litoral - Itajaí | Itajaí | Santa Catarina | Brazil | |
| 14 | INCA | Rio de Janeiro | Brazil | ||
| 15 | Hospital São José | Sao Paulo | Brazil | ||
| 16 | Instituto Brasileiro de Controle do Câncer - IBCC | São Paulo | Brazil |
Sponsors and Collaborators
- Latin American Cooperative Oncology Group
- EVA - Grupo Brasileiro de Tumores Ginecológicos
- Roche Pharma AG
Investigators
- Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
- Hellner K, Münger 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.
- 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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
- Martínez-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.
- Muñoz 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. Review.
- 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.
- 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.
- LACOG 0215/EVA 001