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Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer (GOGER-01)

Primary Purpose

Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma

Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
carboplatin and paclitaxel followed by surgery
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring neoadjuvant chemotherapy, ovarian cancer, fallopian tube carcinoma, peritoneal carcinoma, randomized study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • S.Orsola-Malpighi Hospital
  • Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica
  • IRCCS Ospedale Santa Maria Nuova
  • Fondazione Policlinico Universitario A. Gemelli
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: 3 courses

Arm B: 6 courses

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Rate of progression-free survival
To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer progression-free survival.
Health related quality of life
To compare the quality of life in the two treatment groups
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).
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.
Rate of overall survival
To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer overall survival.

Full Information

First Posted
April 17, 2014
Last Updated
December 28, 2022
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02125513
Brief Title
Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma
Keywords
neoadjuvant chemotherapy, ovarian cancer, fallopian tube carcinoma, peritoneal carcinoma, randomized study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: 3 courses
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm B: 6 courses
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carboplatin and paclitaxel followed by surgery
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety
Description
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
Title
Percentage of patients with pathological complete response
Description
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.
Time Frame
after surgery, up to 1 month after surgery
Title
Rate of progression-free survival
Description
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
Title
Health related quality of life
Description
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)
Title
Rate of radiological responses
Description
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
Title
Rate of decrease of CA125 levels during NACT
Description
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)
Title
Rate of overall survival
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Zamagni, MD
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.Orsola-Malpighi Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
IRCCS Ospedale Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia
City
Udine
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer

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