Cervical CancerPOCERNCT01825005
Predicting Outcome in Cervix Carcinoma: a Prospective Study
An observational study of Cervical Cancer, run by Maastricht Radiation Oncology at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- Type of treatment
- Injection or infusion
- How many people
- 423 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2013to Aug 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with cervical cancer can be included in the study.
Who may be able to join
- histological or cytological proven cervical cancer
- informed consent according to national rules
Who cannot join
- no histological or cytological proven cervical cancer
- no informed consent according to national rules
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this 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.
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
five-year overall survival rate
assessment of the overall survival 5 years after treatment
Measured: 5 years after treatment
Secondary outcomes (6)
three-year distant disease free survival
assessment of distant disease free survival, 3 years after treatment
Measured: 3 years
three-year local disease free survival
assessment of local disease free survival, 3 year after treatment
Measured: 3 years
five-year distant disease free survival
assessment of distant disease free survival,5 years after treatment
Measured: 5 years
five-year local disease free survival
assessment of local disease free survival, 5 years after treatment
Measured: 5 years
number of participants with early adverse events as a measure of safety and tolerability
Measured: 2 months
number of participants with late adverse events as a measure of safety and tolerability
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P Lambin, Prof, Principal investigator, Maastricht University hospital, dep of radiotherapy (Maastro clinic)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825005
- Sponsor's protocol ID
- 12-4-008
- Acronym
- POCER
- Status last verified
- May 2019
- First submitted
- 12 Mar 2013
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcome in Cervix Carcinoma: a Prospective Study
- ClinicalTrials.gov ID
- NCT01825005
- Acronym / sponsor ID
- POCER / 12-4-008
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with cervical cancer can be included in the study.
Key inclusion criteria (2 listed)
- histological or cytological proven cervical cancer
- informed consent according to national rules
Key exclusion criteria (2 listed)
- no histological or cytological proven cervical cancer
- no informed consent according to national rules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
five-year overall survival rate
Time frame: 5 years after treatment
assessment of the overall survival 5 years after treatment
6 secondary outcomes
three-year distant disease free survival
Time frame: 3 years
three-year local disease free survival
Time frame: 3 years
five-year distant disease free survival
Time frame: 5 years
five-year local disease free survival
Time frame: 5 years
number of participants with early adverse events as a measure of safety and tolerability
Time frame: 2 months
number of participants with late adverse events as a measure of safety and tolerability
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P Lambin, Prof principal investigator
Maastricht University hospital, dep of radiotherapy (Maastro clinic)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Maastricht Radiation Oncology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
five-year overall survival rate (time frame: 5 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.