Predicting Outcome in Cervix Carcinoma: a Prospective Study
POCER
1 other identifier
observational
423
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 10, 2019
May 1, 2019
5.5 years
March 12, 2013
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
five-year overall survival rate
assessment of the overall survival 5 years after treatment
5 years after treatment
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
group 1:surgery
treatment = surgery only
group 2: radiotherapy
treatment = radiotherapy only
group 3: RT and CT, and/or hyperthermia
treatment= radiotherapy combined with chemotherapy and/or hyperthermia
group 4: stage IVb , any treatment
cervical cancer stage IV b, treatment = any systemic or radiation therapy and supportive care
Eligibility Criteria
All patients with cervical cancer can be included in the study.
You may qualify if:
- histological or cytological proven cervical cancer
- informed consent according to national rules
You may not qualify if:
- no histological or cytological proven cervical cancer
- no informed consent according to national rules
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Maastricht University Hospital
Maastricht, Netherlands
Bloemfontein medicross
Bloemfontein, Free State, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P Lambin, Prof
Maastricht University hospital, dep of radiotherapy (Maastro clinic)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
April 5, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
May 10, 2019
Record last verified: 2019-05