Predicting Outcome in Cervix Carcinoma: a Prospective Study

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT01825005
• Lead Sponsor: Maastricht Radiation Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 423

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
five-year overall survival rate	5 years after treatment	assessment of the overall survival 5 years after treatment

Secondary Outcome Measures

Name	Time	Method
three-year distant disease free survival	3 years	assessment of distant disease free survival, 3 years after treatment
three-year local disease free survival	3 years	assessment of local disease free survival, 3 year after treatment
five-year distant disease free survival	5 years	assessment of distant disease free survival,5 years after treatment
five-year local disease free survival	5 years	assessment of local disease free survival, 5 years after treatment
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

Trial Locations

Locations (2)

Maastricht University Hospital; 🇳🇱 Maastricht, Netherlands

Bloemfontein medicross; 🇿🇦 Bloemfontein, Free State, South Africa