Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

Cervix Cancer Clinical Trial

Official title:

Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671071
• Other study ID #: LACOG 0215/EVA 001
• Status: Completed
• Start date: April 2016
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	UFMG	Belo Horizonte	Minas Gerais
Brazil	Hospital Geral de Roraima	Boa Vista	Roraima
Brazil	HU Walter Cantídeo	Ceara	Fortaleza
Brazil	Hospital Erasto Gaertner	Curitiba	Paraná
Brazil	CEPON	Florianopolis	Santa Catarina
Brazil	CRIO	Fortaleza	Ceará
Brazil	Centro de Novos Tratamentos Litoral - Itajaí	Itajaí	Santa Catarina
Brazil	Fundação Centro de Controle do Câncer do Estado do Amazonas	Manaus	Amazonas
Brazil	Hospital São Vicente de Paulo	Passo Fundo	Rio Grande Do Sul
Brazil	CPO - Hsl/Pucrs	Porto Alegre	Rio Grande Do Sul
Brazil	IMIP	Recife	Pernambuco
Brazil	INCA	Rio de Janeiro
Brazil	Clínica AMO	Salvador	Bahia
Brazil	Hospital Alderona Bello	Sao Luis	Maranhão
Brazil	Hospital São José	Sao Paulo
Brazil	Instituto Brasileiro de Controle do Câncer - IBCC	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	EVA - Grupo Brasileiro de Tumores Ginecológicos, Roche Pharma AG

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of cervix cancer in the Brazilian female population		3 years
Secondary	Socio-demographic characteristics of the female population diagnosed with CC		Month 0 (beginning of the study)
Secondary	Description of the method used to diagnose the brazillian female patients with cervix cancer	Screening tests (Papanicolaou test) or symptoms presented by patients	Month 0
Secondary	The clinical and pathological characteristics of cervix cancer in brazilian female patients		Month 0
Secondary	Type of treatment assessed in patients with CC	Radiotherapy, Chemotherapy and/or Surgery	Month 0, 3, 6,12, 24 and 36
Secondary	Number of patients with disease survival		Month 3, 6, 12, 24 and 36
Secondary	Number of patients with progression survival		Month 3, 6, 12, 24 and 36
Secondary	Number of patients with overall survival		Month 3, 6, 12, 24 and 36
Secondary	Number of patients with disease overall survival		Month 3, 6, 12, 24 and 36
Secondary	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
Secondary	Duration of treatment after the diagnosis of cervix cancer		Month 0, 3, 6,12, 24 and 36
Secondary	Description of adverse effects of the cervix cancer treatment		Month 0, 3, 6,12, 24 and 36
Secondary	Number of adverse effects of the cervix cancer treatment		Month 0, 3, 6,12, 24 and 36
Secondary	Type of clinical outcomes of the patients with cervix cancer in Brazil		Month 0, 3, 6,12, 24 and 36