Clinical trial NCT01764217: Prediction of Clinical Response and Outcome in Uterine Cervix Cancer
Official title: Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Cancer
Keywords: Cervix Cancer
SUV
Radiotherapy
Outcome Prediction
Imaging
PET
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2013-01-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of SUV-related tumor characteristics predicting recurrence
timeFrame: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed
Secondary outcomes:
measure: Change of SUV-related tumor characteristics predicting clinical overall response
timeFrame: Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
measure: Radiomics Features
timeFrame: Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.
measure: Interobserver variability of Gross Tumor Volume (GTV) contours
timeFrame: GTV's will be delineated 2 weeks after the end of accrual
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Philippe Lambin
state: Limburg
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: philippe Lambin
role: PRINCIPAL_INVESTIGATOR
References: