Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

NCT ID: NCT01764217

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-01-31

Brief Summary

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Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

Detailed Description

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This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Conditions

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Cervix Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed cervix carcinoma (all subtypes)
* Tumor Stages FIGO IB - IVA
* Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
* pre treatment FDG PETCT
* The patient is willing and capable to comply with study procedures
* 18 years or older
* Written informed consent to the treatment

Exclusion Criteria

* Recent (\< 3 months) myocardial infarction
* Uncontrolled infectious disease
* Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
* Previous surgery to the Cervix
* Previous radiation to the Cervix
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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philippe Lambin

Role: PRINCIPAL_INVESTIGATOR

Maastro Clinic, The Netherlands

Locations

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Philippe Lambin

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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CERVMA01

Identifier Type: -

Identifier Source: org_study_id

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