Paclitaxel i.v. Plus Cisplatin i.p for NACT in Patients With Advanced Ovarian Cancer

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

To test the effect of intravenous paclitaxel plus intraperitoneal cisplatin for neo-adjuvant chemotherapy in patients with advanced ovarian cancer, the investigators conducted a phase III single arm clinical trial. Included patients will receive interval debulking surgery after 2-6 cycles neoadjuvant chemotherapy based on the clinical judgment of the gynecologic oncologist. Six cycles of chemotherapy will conducted after surgery. And the neoadjuvant chemotherapy is as follows: paclitaxel 135 mg/m2 i.v. and cisplatin 75 mg/m2 i.p. on day 1. The primary end point is optimal debulking rates. the investigators also will evaluate effect on parameters of volume of ascites, tumor size, duration of surgery, hemorrhage, hospitalizations and postoperative complication etc. After comparing with data published online, the investigators will try to find out if paclitaxel i.v. plus cisplatin i.p. is a superior neoadjuvant chemotherapy for advanced ovarian carcinoma.

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

Details

• Lead Sponsor: West China Second University Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Preferentially biopsy proven Stage IIIc or IV epithelial ovarian carcinoma, or peritoneal or fallopian tube carcinoma (the presence of metastases outside the pelvis measuring at least 2 cm in diameter (as noted during diagnostic laparoscopy or laparotomy or on computed tomography [CT]),with a low likelihood of achieving cytoreduction to, 1 cm (ideally to no visible disease). Or women who have a high perioperative risk profile.

2. Fine needle aspiration (FNA) showing an adenocarcinoma and cytopathology from ascites or pleural effusion is acceptable under the following conditions:

the patient has a pelvic (ovarian) mass, AND omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymphnode metastasis irrespective of size or stage IV AND serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) should be negative for the presence of a primary tumor (< 6 weeks before randomization), and normal mammography (< 6 weeks).

3. WHO performance status of 0, 1, or 2.

4. No other serious disabling diseases contraindicating for cytoreductive surgery or platin based chemotherapy.

5. No other prior primary malignancies, except for carcinoma in situ of the cervix and basal carcinoma of the skin.

6. No clinical evidence of brain or leptomeningeal metastases.

7. Adequate hematological, renal and hepatic function to permit platin-paclitaxel based chemotherapy: WBC > 3.0 x 109/L, N >1.5 x 109/L, platelets > 100 x 109/L, serum creatinine < 1.25 x upper normal range, serum bilirubin < 1.25 x upper normal range.

8. Absence of any psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.

9. Before patient registration/randomization, informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.

Exclusion Criteria:

1. serious disabling diseases that would contraindicate primary cytoreductive surgery or platinumbased chemotherapy

2. mucinous or borderline histology, extensive intra-abdominal adhesions, bowel obstruction or unresolved>grade 2 peripheral neuropathy.