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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01825005
Recruitment Status : Suspended (logistics)
First Posted : April 5, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Cervical Cancer

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Predicting Outcome in Cervix Carcinoma: a Prospective Study
Study Start Date : February 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. five-year overall survival rate [ Time Frame: 5 years after treatment ]
    assessment of the overall survival 5 years after treatment


Secondary Outcome Measures :
  1. three-year distant disease free survival [ Time Frame: 3 years ]
    assessment of distant disease free survival, 3 years after treatment

  2. three-year local disease free survival [ Time Frame: 3 years ]
    assessment of local disease free survival, 3 year after treatment

  3. five-year distant disease free survival [ Time Frame: 5 years ]
    assessment of distant disease free survival,5 years after treatment

  4. five-year local disease free survival [ Time Frame: 5 years ]
    assessment of local disease free survival, 5 years after treatment

  5. number of participants with early adverse events as a measure of safety and tolerability [ Time Frame: 2 months ]
  6. number of participants with late adverse events as a measure of safety and tolerability [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with cervical cancer can be included in the study.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825005


Locations
Netherlands
Maastricht University Hospital
Maastricht, Netherlands
South Africa
Bloemfontein medicross
Bloemfontein, Free State, South Africa
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: P Lambin, Prof Maastricht University hospital, dep of radiotherapy (Maastro clinic)
More Information

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01825005     History of Changes
Other Study ID Numbers: 12-4-008
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Maastricht Radiation Oncology:
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female