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

Fallopian Tube Cancer Clinical Trial

— Mupet  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01276574
• Other study ID #: 53/180/2009
• Status: Active, not recruiting
• Start date: October 2009
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Cancer

Locations

Country	Name	City	State
Finland	Turku University hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery
Secondary	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.	Outcome measure: after interval debulking surgery, about 4 months
Secondary	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	From diagnosis until the end of EOC primary therapy, about 8 months
Secondary	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.	PET/CT taken about 4 weeks after the last chemotherapy cycle
Secondary	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	Long time follow up ad 10 years