Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

Maastricht Radiation Oncology

Status: Completed

Conditions: Cervix Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01764217

CERVMA01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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