Reduction Of Cycles of neOadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Te hypothesized that two cycles of neoadjuvant chemotherapy followed by interval debulking surgery would improve survival in advanced epithelial ovarian, fallopian, and primary peritoneal cancer because reduction of one cycle of chemotherapy can lead to the removal of more tumor burden, compared with three cycles of neoadjuvant chemotherapy.

So the investigators aim to compare survival, rate of successful optimal cytoreductive surgery, post-operative complications, and quality of life between two and three cycles of neoadjuvant chemotherapy followed by interval debulking surgery for advanced epithelial ovarian, fallopian, and primary peritoneal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Age: 20-80 years old

2. Advanced epithelial ovarian, fallopian or primary peritoneal cancer diagnosed with the following methods

• Histologic confirmation by diagnostic laparoscopic or laparotomy ② Histologic malignancy originated from female genital tract on fine needle aspiration 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 performance status 0-2

5. The following criteria should be met if synchronous or metachronous tumors exists.

① Complete remission of metachronous malignancy for at least 5 years

② Follicular or papillary thyroid cancer treated completely with only surgery as a synchronous tumor

③ Early gastric or colon cancer treated completely with only endoscopic mucosal resection as a synchronous 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, onco-thermia, herbal medicine, etc.)

8. No informed consent