Predicting Outcome in Cervix Carcinoma: a Prospective Study (POCER)

May 9, 2019 updated by: Maastricht Radiation Oncology
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Hospital
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa
        • Bloemfontein medicross

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients with cervical cancer can be included in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five-year overall survival rate
Time Frame: 5 years after treatment
assessment of the overall survival 5 years after treatment
5 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
three-year distant disease free survival
Time Frame: 3 years
assessment of distant disease free survival, 3 years after treatment
3 years
three-year local disease free survival
Time Frame: 3 years
assessment of local disease free survival, 3 year after treatment
3 years
five-year distant disease free survival
Time Frame: 5 years
assessment of distant disease free survival,5 years after treatment
5 years
five-year local disease free survival
Time Frame: 5 years
assessment of local disease free survival, 5 years after treatment
5 years
number of participants with early adverse events as a measure of safety and tolerability
Time Frame: 2 months
2 months
number of participants with late adverse events as a measure of safety and tolerability
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: P Lambin, Prof, Maastricht University hospital, dep of radiotherapy (Maastro clinic)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-4-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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