Clinical trial NCT02125513: Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Carcinoma
Peritoneal Carcinoma
Keywords: neoadjuvant chemotherapy
ovarian cancer
fallopian tube carcinoma
peritoneal carcinoma
randomized study
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgery , as a comparative outcome measure of 3 vs 6 courses of neoadjuvant chemotherapy
timeFrame: within 6 weeks after the last cycle of chemotherapy
Secondary outcomes:
measure: Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety
timeFrame: within 30 days after surgery
measure: Percentage of patients with pathological complete response
timeFrame: after surgery, up to 1 month after surgery
measure: Rate of progression-free survival
timeFrame: from date of randomization until the date of disease progression or second cancer or death from any cause, whichever occurs first, assessed for 10 years after the end of chemotherapy
measure: Health related quality of life
timeFrame: from baseline to safety follow-up visit (30-34 days after surgery)
measure: Rate of radiological responses
timeFrame: at the end of neoadjuvant chemotherapy, before surgery
measure: Rate of decrease of CA125 levels during NACT
timeFrame: from cycle 1 of chemotherapy to safety follow-up visit (30-34 days after surgery)
measure: Rate of overall survival
timeFrame: from date of randomization until date of death due to any cause, assessed until 10 years after the end of chemotherapy
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S.Orsola-Malpighi Hospital
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica
city: Reggio Emilia
country: Italy
facility: IRCCS Ospedale Santa Maria Nuova
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Claudio Zamagni, MD
role: PRINCIPAL_INVESTIGATOR
References: