Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer

NCT ID: NCT02125513

Last Updated: 2022-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2023-12-31

Brief Summary

The purpose 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 epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Conditions

Ovarian Cancer; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Keywords

neoadjuvant chemotherapy; ovarian cancer; fallopian tube carcinoma; peritoneal carcinoma; randomized study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: 3 courses

Patients will receive 3 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15.

Group Type: ACTIVE_COMPARATOR

carboplatin and paclitaxel followed by surgery

Intervention Type: DRUG

Arm B: 6 courses

Patients will receive 6 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15.

Group Type: EXPERIMENTAL

carboplatin and paclitaxel followed by surgery

Intervention Type: DRUG

Interventions

carboplatin and paclitaxel followed by surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients ≥18 years.
• Karnofsky Performance Scale ≥ 60%
• Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
• Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV oligometastatic unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy.
• Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:

• white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement
• serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
• Signed informed consent obtained prior to any study-specific procedures

Exclusion Criteria

• Mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
• 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).
• 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.
• 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).
• Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Claudio Zamagni MD

MD Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Zamagni, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

S.Orsola-Malpighi Hospital

Bologna, , Italy

Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica

Parma, , Italy

IRCCS Ospedale Santa Maria Nuova

Reggio Emilia, , Italy

Fondazione Policlinico Universitario A. Gemelli

Rome, , Italy

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia

Udine, , Italy

Countries

Italy

Other Identifiers

2013-002520-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GOGER-01

Identifier Type: -

Identifier Source: org_study_id