Mupet: Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT

Sponsor

Turku University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01276574

Collaborator

(none)

150

Enrollment

Location

159

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC)

Objectives
the impact of preoperative PET/CT compared to CT on EOC stage definition
to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard.
to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen

with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of EOC

to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG criteria
Methods
All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant chemotherapy (NACT) and 4 weeks after completion of primary platinum-based chemotherapy.
CA125 and HE4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

PET/CT (positron emission tomography/computed tomography)compared with contrast-enhanced CT in preoperative evaluation of disease burden in patients with advanced Epithelial ovarian cancer (EOC). [PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery]
Patient is scanned with whole body Fdg PET/CT and contrast-enhanced CT in a row within 3 weeks preoperatively. Findings are compared with intraoperative surgical status evaluated by operator and confirmed with biopsies.

Secondary Outcome Measures

Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy [Outcome measure: after interval debulking surgery, about 4 months]
Fdg PET/CT and a contrast-enhanced CT are performed in a row at the time of diagnosis and repeated after 3 cycles of chemotherapy. Finding are compared with disease status in the interval debulking surgery evaluated by operator and histological specimen.
Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer) [From diagnosis until the end of EOC primary therapy, about 8 months]
HE4 and CA125 are measured at the time of diagnosis, perioperatively, and at each chemotherapy cycle (6-9). Treatment outcome is evaluated with contrast-enhanced CT at the end of primary therapy. HE4 and CA125 are compared with each other in different treatment outcomes (complete response, partial response, stable disease and progression) and PFS and OS
Response to first line treatment: evaluation with PET/CT [PET/CT taken about 4 weeks after the last chemotherapy cycle]
Treatment outcome measured with RECIST 1.1 and GCIG criteria is compared with PET/CT results. The prognostic role of persistent metabolic activity in PET/CT is evaluated.
HE4 and CA125 in 1st relapse [Long time follow up ad 10 years]
Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed patients with advanced epithelial ovarian, primary peritoneal cancer or fallopian tube cancer.
age 18-79 years
informed concent

Exclusion Criteria:

diabetes (for PET/CT analyses)
previous cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turku University hospital	Turku		Finland	20521

Sponsors and Collaborators

Turku University Hospital

Investigators

Study Director: Seija Grénman, professor, Turku University hospital, Department of Obstetrics and Gynecology
Principal Investigator: Johanna Hynninen, MD, PhD, Turku University hospital, Department of Obstetrics and Gynecology
Principal Investigator: Tuulia Vallius, MD, Turku University hospital, Dep of Ob/gyn and Dep of oncology