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

Overview

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.

Full Title of Study: “Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions – The EVITA I Study”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Characterization of cervix cancer in the Brazilian female population
    • Time Frame: 3 years

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Latin American Cooperative Oncology Group
  • Collaborator
    • EVA – Grupo Brasileiro de Tumores Ginecológicos
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gustavo Werutsky, MD, Study Director, Latin American Cooperative Oncology Group
  • Overall Contact(s)
    • Laura Voelcker, 55 51 3384 5334, laura.voelcker@lacog.org.br

References

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.

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.

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.

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.

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.

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