Trial intelligence / Profile preview

3 vs 6 Courses of Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

NCT02125513Phase 2

Key facts

Status: Unknown
Start: Jan 2014
Primary completion: May 2021
Countries: 1
Sponsor: Sant'Orsola-Malpighi University Hospital
Modality: DNA Intercalators/Alkylators

Drugs: carboplatinpaclitaxel
Conditions: epithelial ovarian cancer (EOC)fallopian tube carcinoma (PFTC)primary peritoneal carcinoma (PPC)

Overview

Phase 2, randomised, open-label trial of carboplatin and paclitaxel in epithelial ovarian cancer (EOC), fallopian tube carcinoma (PFTC) and primary peritoneal carcinoma (PPC) (2 arms), sponsored by Sant'Orsola-Malpighi University Hospital. Primary endpoint: Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgery. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

3 courses
3 courses of carboplatin + paclitaxel followed by surgery
6 courses
6 courses of carboplatin + paclitaxel followed by surgery

Who it enrols

Female patients >=18 years with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (excluding mucinous, clear cell, low-grade, and carcinosarcoma). Must have FIGO stage IIIC-IV oligometastatic disease unsuitable for primary surgery. Adequate bone marrow, liver, and renal function required.

Endpoints

Primary

Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgerywithin 6 weeks after the last cycle of chemotherapy

Secondary

Percentage of patients with grade 3-5 perioperative toxicitywithin 30 days after surgery
Percentage of patients with pathological complete responseup to 1 month after surgery
Rate of progression-free survival10 years
Health related quality of life30-34 days after surgery
Rate of radiological responsesbefore surgery
Rate of decrease of CA125 levels during NACT30-34 days after surgery
Rate of overall survival10 years

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