Reduction of cycles of neoadjuvant chemotherapy for advanced epithelial ovarian, fallopian, and primary peritoneal cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003532
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

(1) Age: 18-80 years old
(2) Advanced epithelial ovarian, fallopian or primary peritoneal cancer diagnosed with the following methods
? Histologic confirmation by diagnostic laparoscopic or laparotomy
? Hisologic malignancy originated from female genital tract on fine needle aspiartion if histological confirmation is difficult or cytologic confirmation of adenocarcinoma in ascites if fine needle aspiration is difficult, meeting the following criteria
- Existence of the pelvic or ovarian mass
- Identification of tumor >2 cm beyond the pelvis on CT, malignant pleural effusion by thoracentesis, extraperitoneal lymph node metastasis (cardio-phrenic, internal mammary, mediastinal, para-tracheal, supraclavicular lymph nodes or inguinal lymph nodes)
- Cancer antigen 125 (CA-125, kU/L)/carcinoembryonic antigen (CEA, ng/ml) >25
- if CA-125 (kU/L)/CEA (ng/ml) is 25 or less, no primary lesion on colonoscopy, gastroscopy and mammography within six weeks before randomization.
(3) International Federation of Gynecology and Obstetrics(FIGO) stage IIIC to IVB disease
(4) World Health Organization(WHO) performance status 0-2
(5) The following criteria should be met if synchronous or metachronous tumors excisit.
? Complete remission of metachronous malignancy for at least 5 years
? Follicular or papillary thyroid cancer treated completely with only surgery as a synchronous tumor
? Early gastric or colon cancer treated completely with only endoscopic mucosal resection as a synchrounous tumor
(6) Normal hematologic, renal and liver function with the following criteria
White blood cell(WBC) =3,000/ul
Absolute neutrophil count(ANC) =1,500/ul
Platelet =100×103/ul
Aspartate aminotransferase(AST) =100 IU/L
Alanine aminotransferase(ALT) =100 IU/L
Serum total bilirubin =1.5 mg/dL
Serum creatinine =1.5 mg/dL
(7) Absence of psychological, and socioeconomic limitations affecting participation to this trial
(8) Informed consent

Exclusion Criteria

(1) Diagnosis of metachronous malignancy within five years before enrollment
(2) Synchronous tumors except follicular or papillary thyroid cancer treated completely with only surgery and early gastric or colon cancer treated completely with only endoscopic mucosal resection
(3) Carcinoma in situ, non-epithelial, or borderline tumor in ovary, fallopian tube, and peritoneum
(4) Pregnancy
(5) Medical conditions (hypertension, diabetes mellitus, infectious or cardiac disease etc.) influencing on survival
(6) Clinical evidence of brain or leptomeningeal metastasis, bone metastasis
(7) Other treatments affecting clinical outcomes during participation to this trial (hyperthermic intraperitoneal chemotherapy, oncothermia, herbal medicine, etc.)
(8) No informed consent

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (the time interval from randomization date to disease recurrence or progression date)