Predicting Outcome in Cervix Carcinoma: a Prospective Study

Maastricht Radiation Oncology2 sites in 2 countries423 target enrollmentFebruary 2013

ConditionsCervical Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Maastricht Radiation Oncology
Enrollment: 423
Locations: 2
Primary Endpoint: five-year overall survival rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

August 2018

Last Updated

6 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Maastricht Radiation Oncology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•histological or cytological proven cervical cancer
•informed consent according to national rules

Exclusion Criteria

•no histological or cytological proven cervical cancer
•no informed consent according to national rules

Outcomes

Primary Outcomes

five-year overall survival rate

Time Frame: 5 years after treatment

assessment of the overall survival 5 years after treatment

Secondary Outcomes

three-year distant disease free survival(3 years)
three-year local disease free survival(3 years)
five-year distant disease free survival(5 years)
five-year local disease free survival(5 years)
number of participants with early adverse events as a measure of safety and tolerability(2 months)
number of participants with late adverse events as a measure of safety and tolerability(5 years)