Study of Upfront surgery versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients with Stage IIIC and IV Ovarian Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0005870
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 456
3.1
3.1.1 Women aged = 18 years.
3.1.2 Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or
primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic
biopsy with pictures is recommended.
* If fine needle aspiration (FNA) showing an adenocarcinoma, patients should satisfy the
following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis
larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis,
and c. serum CA125/CEA ratio>25. If serum CA125/CEA ratio <25 or malignancies of other
origins, such as breasts and digestive tract, are suspected from symptoms, physical
examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive
metastasis ovarian cancer.
3.1.3 ECOG performance status of 0 to 2.
3.1.4 ASA score of 1 to 2.
3.1.5 Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to
undergo surgery:
? white blood cells >3,000/µL, absolute neutrophil count =1,500/µL, platelets =100,000/µL,
hemoglobin =9 g/dL,
? serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance =60 mL/min
according to Cockroft-Gault formula or to local lab measurement,
? serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
3.1.6 Comply with the study protocol and follow-up.
3.1.7 Written informed consent.
3.2.1 Patients with non-epithelial tumors as well as borderline tumors.
3.2.2 Low-grade carcinoma. (09/22/2016)
3.2.3 Mucinous ovarian cancer.
3.2.4 Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
3.2.5 Any other concurrent medical conditions contraindicating surgery or chemotherapy that could
compromise the adherence to the protocol.
3.2.6 Other conditions, such as religious, psychological and other factors, that could interfere with
provision of informed consent, compliance to study procedures, or follow-up.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival;Progression-tree survival;Adverse Events;Treatment-Free Intervals
- Secondary Outcome Measures
Name Time Method Quality of life assessments