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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
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
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
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
Time frame: within 6 weeks after the last cycle of chemotherapy
Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety
To determine whether a longer duration of neoadjuvant chemotherapy is associated with a lower rate of perioperative grade 3-5 toxicities. The surgical adverse events are defined as: * intraoperative, which occur during surgical procedure * perioperative , which occur from day 1 to day 7 after surgery * postoperative, which occur from day 8 to 30 days after surgery Adverse events list for surgical procedures: Postoperative death (\<30 days); Hemorrhage/bleeding intraoperative or postoperative requiring at least transfusion of 2 units of non-autologous red blood cells; Vascular events: thrombosis/embolism, disabling or life-threatening vessel injury-artery or vein, symptomatic or life-threatening visceral arterial ischemia; Infections requiring IV antibiotics, antifungal or antiviral interventions or at risk for life-threatening consequences; Gastrointestinal fistula; Urinary fistula; Lymphocele, requiring medical or operative intervention.
Time frame: within 30 days after surgery
Percentage of patients with pathological complete response
To determine whether a longer duration of neoadjuvant chemotherapy is associated with higher rate of pathological complete response. Complete pathological response is defined as the absence of cancer cells in surgical specimens, and very good partial remission is defined as the persistence of only small clusters (\< 1 cm) or individual cancer cells and no macroscopic residual after surgery. Partial pathological remission is defined as a tumor burden reduction between 30 and 90% at surgery, while stable disease is defined as no tumour burden reduction or reduction lower than 30% at surgery, compared with initial diagnostic laparoscopy. Only patients with complete and very good partial remissions are considered as pathological responders, while all the other cases are considered as pathological non-responders.
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Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia
Udine, Italy
Time frame: after surgery, up to 1 month after surgery
Rate of progression-free survival
To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer progression-free survival.
Time frame: 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
Health related quality of life
To compare the quality of life in the two treatment groups
Time frame: from baseline to safety follow-up visit (30-34 days after surgery)
Rate of radiological responses
To determine whether a longer duration of neoadjuvant chemotherapy is associated with a higher rate of radiological responses (according to RECIST 1.1 criteria).
Time frame: at the end of neoadjuvant chemotherapy, before surgery
Rate of decrease of CA125 levels during NACT
To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA125 levels.
Time frame: from cycle 1 of chemotherapy to safety follow-up visit (30-34 days after surgery)
Rate of overall survival
To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer overall survival.
Time frame: from date of randomization until date of death due to any cause, assessed until 10 years after the end of chemotherapy