Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

NCT01764217 | Completed

• 1 other identifier: CERVMA01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Cancer

Keywords

Cervix Cancer; SUV; Radiotherapy; Outcome Prediction; Imaging; PET

Outcome Measures

Primary Outcomes (1)

• Change of SUV-related tumor characteristics predicting recurrence

  * Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg), * Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix

  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 (3)

• Change of SUV-related tumor characteristics predicting clinical overall response

  Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.

• Radiomics Features

  Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.

• Interobserver variability of Gross Tumor Volume (GTV) contours

  GTV's will be delineated 2 weeks after the end of accrual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

You may qualify if:

• 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
• years or older
• Written informed consent to the treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator

Study Sites (1)

Philippe Lambin

Maastricht, Limburg, 6202NA, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• philippe Lambin

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: January 9, 2013
• Study Start: July 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: January 1, 2013
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

NL (1)