Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT
This trial is active, not recruiting.
|Conditions||epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer|
|Sponsor||Turku University Hospital|
|Start date||October 2009|
|End date||December 2017|
|Trial size||150 participants|
|Trial identifier||NCT01276574, 53/180/2009|
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)
- 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
- 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 and with every chemotherapy cycle.
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).
time frame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery
Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy
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)
time frame: From diagnosis until the end of EOC primary therapy, about 8 months
Response to first line treatment: evaluation with PET/CT
time frame: PET/CT taken about 4 weeks after the last chemotherapy cycle
Female participants from 18 years up to 79 years old.
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 - previous cancer
|Official title||Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)|
|Principal investigator||Johanna Hynninen, MD, PhD|
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