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Completed

NCT Number: NCT01825005

Predicting Outcome in Cervix Carcinoma: a Prospective Study

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maastricht University Hospital, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. five-year overall survival rate

    Time frame: 5 years after treatment

    assessment of the overall survival 5 years after treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Acronym: POCER

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2013
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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