Randomized phase II study of 3 vs 6 courses of neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002520-17-IT

Enrollment

220

Registered

2013-10-07

Start date

2013-11-27

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neoadjuvant carboplatin-paclitaxel chemotherapy in stage IIIC or IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma MedDRA version: 16.0 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and uns

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: carboplatin Other descriptive name: CARBOPLATIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: PACLITAXEL CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must fulfill all the following eligibility criteria in order to be eligible for this study: a. Female patients =18 years. b. Karnofsky Performance Scale = 60% (see Appendix I). c. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell and carcinosarcoma histologies. d. Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy. e. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: • white blood cells (WBC) >3,000/µL, absolute neutrophil count (ANC) =1,500/µL, platelets (PLT) =100,000/µL, hemoglobin (Hb) =9 g/dL, • serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: a. Mucinous, clear cell and carcinosarcoma histologies. b. Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites). c. Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study. d. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders). e. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.;Secondary Objective: ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a lower rate of perioperative grade 3 and 4 morbidity and perioperative mortality. ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a higher rate of radiological responses (according to RECIST criteria, version 1.1) [29]. See Section 13.2 for radiological response evaluation. ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA 125 levels. See Section 13.3 for CA 125 response evaluation. ;Primary end point(s): The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.;Timepoint(s) of evaluation of this end point: maximum of 8 months (encluded 1 month follow-up after the surgery)	—

Measure

Time frame

Main Objective: The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.;Secondary Objective: ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a lower rate of perioperative grade 3 and 4 morbidity and perioperative mortality. ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a higher rate of radiological responses (according to RECIST criteria, version 1.1) [29]. See Section 13.2 for radiological response evaluation. ?To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA 125 levels. See Section 13.3 for CA 125 response evaluation. ;Primary end point(s): The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. See Section 13.1 for Surgical evaluation.;Timepoint(s) of evaluation of this end point: maximum of 8 months (encluded 1 month follow-up after the surgery)

—

Secondary

Measure	Time frame
Secondary end point(s): To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA 125 levels. See Section 13.3 for CA 125 response evaluation.;Timepoint(s) of evaluation of this end point: maximum of 8 months (encluded 1 month follow-up after the surgery)	—

Countries

Italy

Contacts

Public ContactSSD Oncologia-Zamagni

AOU di Bologna

claudio.zamagni@aosp.bo.it00390516364548

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026