Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer

Sponsor

National Institute of Cancerología (Other)

Overall Status

Completed

CT.gov ID

NCT04537273

Collaborator

(none)

1,954

Enrollment

186.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Locally advanced cervical cáncer continues to be a public health problem in emergent economies, even though treatment is very well standardized, recurrence rate is still high, making necessary to evaluate prognostic clinical and pathological factors. The aim of this study is to evaluate clinical and pathological prognostic factor in terms of treatment outcomes, disease-free survival (DFS) and overall survival (OS) in a retrospective cohort of patients with LACC treated with standard chemoradiotherapy in a reference center in México.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Other: Descriptive and analytical

Detailed Description

This is a retrospective study, the data were obtained from clinical files of cervical cancer patients with clinical stages IB2-IVA(FIGO2009) treated at the Instituto Nacional de Cancerología in Mexico City from January 2005 to December 2014.

A total of 1954 patients with LACC confirmed by pathology, clinical exams and computed tomography scan (CT) were identified.

Demographic, clinical, pathological and follow-up as well as survival status of all patients was recorded. Treatment outcome was classified as complete response if the patient had no signs of tumor activity after 6 months of finishing treatment, persistence of disease was defined if tumor could be identified after treatment or before six months of treatment termination, progression was defined if tumor growth occurred or metastatic disease appeared. Disease-free survival (DFS) was defined as the period between finishing treatment and the occurrence of relapse, which was confirmed by pathological study and/or CT. Overall survival (OS) was defined as the time period between diagnosis and death or date at last visit. Quantitative variables were described with central tendency and dispersion measures and analyzed with Student's t or Mann-Whitney U test. Normality was determined with Shapiro-Wilk's test, Chi-squared for categorical comparisons between groups, Kaplan-Meir with the log-rank test for survival analysis were performed. The multivariate analysis was performed using Cox proportional Hazard regression model. Statistically significant differences were defined as a p value <0.05.

Statistical analyses were performed using IBM SPSS, version 23 (IBM Corp., Armonk, N.Y., USA).

Study Design

Study Type:

Observational

Actual Enrollment :

1954 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Clinical and Pathological Characteristics as Prognostic Factors in Locally Advanced Cervical Cancer: A Retrospective Study

Actual Study Start Date :

Jan 2, 2005

Actual Primary Completion Date :

Dec 31, 2014

Actual Study Completion Date :

Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Localy advanced Cervical Cancer Patients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy.	Other: Descriptive and analytical

Arm

Intervention/Treatment

Localy advanced Cervical Cancer

Patients with Localy advanced Cervical Cancer confirmed by pathology, clinical exams and computed tomography scan, treated with concurrent chemoradiotherapy.

Other: Descriptive and analytical

Outcome Measures

Primary Outcome Measures

Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer. [5 years]
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of overall survival.

Secondary Outcome Measures

Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer. [6 months]
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of response rate of treatment.
Analyze the clinical and pathological characteristics as prognostic factor of patients with locally advanced cervical cancer. [5 years]
Analyze the clinical and pathological characteristics of patients with cervical cancer stages IB2 to IVA as prognostic factor in terms of disease-free survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with cervical cancer clinical stage Ib2-IVa
Treated with concomitant Chemoradiotherapy

Exclusion Criteria:

Rare histologies such gastric type adenocarcinoma, neuroendocrine or clear-cell carcinoma
incomplete treatment or not treated with chemoradiotherapy
Two primary malignancies
Insufficient data for analysis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Institute of Cancerología

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Cantu, Md, PhD, National Institute of Cancerología

ClinicalTrials.gov Identifier:

NCT04537273

Other Study ID Numbers:

Rev/050/18

First Posted:

Sep 3, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Cantu, Md, PhD, National Institute of Cancerología

Locally advanced

Cervical carcinoma

Prognostic factors

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Sep 3, 2020