Status:
UNKNOWN
Paclitaxel i.v. Plus Cisplatin i.p for NACT in Patients With Advanced Ovarian Cancer
Lead Sponsor:
West China Second University Hospital
Conditions:
Epithelial Carcinoma, Ovarian
Neoadjuvant Chemotherapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
1. BACKGROUND AND INTRODUCTION Epithelial ovarian cancer (EOC) is the leading cause of death from gynecologic malignancy in the developed world with the majority of women presenting with stage III/IV ...
Eligibility Criteria
Inclusion
- 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.
- 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).
- WHO performance status of 0, 1, or 2.
- No other serious disabling diseases contraindicating for cytoreductive surgery or platin based chemotherapy.
- No other prior primary malignancies, except for carcinoma in situ of the cervix and basal carcinoma of the skin.
- No clinical evidence of brain or leptomeningeal metastases.
- 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.
- 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.
- 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
- serious disabling diseases that would contraindicate primary cytoreductive surgery or platinumbased chemotherapy
- mucinous or borderline histology, extensive intra-abdominal adhesions, bowel obstruction or unresolved\>grade 2 peripheral neuropathy.
Key Trial Info
Start Date :
August 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04885270
Start Date
August 4 2021
End Date
March 1 2024
Last Update
August 10 2021
Active Locations (1)
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1
West China Second University Hospital of Sichuan University
Chengdu, Sichuan, China, 610041