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

NCT01276574Active, Not RecruitingOBSERVATIONAL

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 125) 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

Key Facts

Lead Sponsor

Turku University Hospital

Enrollment

150

Start Date

2009-10-01

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Epithelial Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Eligibility

Age Range

18 Years – 79 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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).

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.

Time frame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery

Secondary Outcomes

Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy

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.

Time frame: Outcome measure: after interval debulking surgery, about 4 months

Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer)

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

Time frame: From diagnosis until the end of EOC primary therapy, about 8 months

Response to first line treatment: evaluation with PET/CT

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.

Time frame: PET/CT taken about 4 weeks after the last chemotherapy cycle

HE4 and CA125 in 1st relapse

Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival

Time frame: Long time follow up ad 10 years

Locations

Turku University hospital, Turku, Finland

Linked Papers

2020-10-08

HE4 in the evaluation of tumor load and prognostic stratification of high grade serous ovarian carcinoma

Human epididymis protein 4 (HE4) is a validated, complementary biomarker to cancer antigen 125 (CA125) for high grade serous ovarian carcinoma (HGSC). Currently, there are insufficient data on the utility of longitudinal HE4 measurement during HGSC treatment and follow up. We set to provide a comprehensive analysis on the kinetics and prognostic performance of HE4 with serial measurements during HGSC treatment and follow up. This prospective study included 143 patients with advanced HGSC (ClinicalTrials.gov identifier: NCT01276574). Serum CA125 and HE4 were measured at baseline, before each cycle of chemotherapy and during follow up until first progression. Baseline biomarker values were compared to the tumor load assessed during surgery and to residual disease. Biomarker nadir values and concentrations at progression were correlated to survival. The baseline HE4 concentration distinguished patients with a high tumor load from patients with a low tumor load assessed during surgery ( HE4 is a feasible biomarker in the treatment monitoring and prognostic stratification of patients with HGSC. Specifically, the serum level of HE4 at first relapse was associated with the survival of patients and it may be a useful complementary tool in the selection of second line treatments. This is to the best of our knowledge the first time this finding has been reported.

Linked Investigators

Johanna Hynninen

Research interest: Ovarian Cancer

Kaisa Huhtinen

Liina Salminen