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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Maastricht Radiation Oncology
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01825005
First received: March 12, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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
Cervical Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Predicting Outcome in Cervix Carcinoma: a Prospective Study

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • five-year overall survival rate [ Time Frame: 5 years after treatment ] [ Designated as safety issue: No ]
    assessment of the overall survival 5 years after treatment


Secondary Outcome Measures:
  • three-year distant disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    assessment of distant disease free survival, 3 years after treatment

  • three-year local disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    assessment of local disease free survival, 3 year after treatment

  • five-year distant disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    assessment of distant disease free survival,5 years after treatment

  • five-year local disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    assessment of local disease free survival, 5 years after treatment

  • number of participants with early adverse events as a measure of safety and tolerability [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • number of participants with late adverse events as a measure of safety and tolerability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825005

Contacts
Contact: L. Lutgens, MD, PhD +31 88 44 55 666 ludy.lutgens@maastro.nl
Contact: C. van Gestel, MD + 31 88 44 55 666 kitty.vangestel@maastro.nl

Locations
Netherlands
Maastricht University Hospital Recruiting
Maastricht, Netherlands
Contact: L Lutgens, MD, PhD    +31 88 44 55 666    ludy.lutgens@maastro.nl   
Principal Investigator: P. Lambin, MD. PhD         
South Africa
Bloemfontein medicross Recruiting
Bloemfontein, Free State, South Africa
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: P Lambin, Prof Maas tricht University hospital, dep of radiotherapy (Maastro clinic)
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01825005     History of Changes
Other Study ID Numbers: 12-4-008
Study First Received: March 12, 2013
Last Updated: March 20, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Diseases
Carcinoma
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014