Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

— GOGER-01  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02125513
• Other study ID #: GOGER-01
• Secondary ID: 2013-002520-17
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: December 2023
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Carcinoma

Intervention

Drug:
• carboplatin and paclitaxel followed by surgery

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 6 weeks after the last cycle of chemotherapy
Secondary	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.	within 30 days after surgery
Secondary	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.	after surgery, up to 1 month after surgery
Secondary	Rate of progression-free survival	To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer progression-free survival.	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
Secondary	Health related quality of life	To compare the quality of life in the two treatment groups	from baseline to safety follow-up visit (30-34 days after surgery)
Secondary	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).	at the end of neoadjuvant chemotherapy, before surgery
Secondary	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.	from cycle 1 of chemotherapy to safety follow-up visit (30-34 days after surgery)
Secondary	Rate of overall survival	To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer overall survival.	from date of randomization until date of death due to any cause, assessed until 10 years after the end of chemotherapy