CISPLATIN for FIGO stage III epithelial ovarian cancer | FIGO stage III fallopian tube cancer | FIGO stage III primary peritoneal cancer

Inclusion criteria

• {"criterion_text":"- signed and written informed consent\n- age ≥18\n- histological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer, treated with primary complete cytoreduction, or primary cytoreduction with no more than 2.5 mm residual disease a. in case of extra-abdominal suspicious lymph nodes, representative cytology/histology or FDG-PET scan must be negative; b. resectable, local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions are allowed; c. in case no histological proof is available before surgery, patients can be randomized during surgery based on histological proof on intraoperative frozen section material\n- fit for major surgery, WHO performance status 0-2\n- adequate bone marrow function (hemoglobin level >5.5 mmol/L; leukocytes >3 x 109/L; platelets >100 x 109 /L)\n- adequate hepatic function (ALT, AST and bilirubin <2.5 times upper limit of normal) a. in case of Gilbert’s disease: unconjugated bilirubin <5 times upper limit of normal\n- adequate renal function (creatinine clearance ≥ 60 ml/min or ml/min/1,73 m2 using either MDRD, Cockcroft-Gault formula, or CKD-EPI)\n- baseline health-outcome questionnaire should be completed before randomization\n- able to understand the patient information and questionnaires."}

Exclusion criteria

• {"criterion_text":"- history of previous malignancy treated with chemotherapy\n- history of previous malignancy within five years prior to inclusion, with the exception of carcinoma in situ, radically excised basal cell or squamous cell cancer of the skin or synchronal endometrial carcinoma FIGO IA G1/2\n- if complete primary cytoreduction is not feasible, for the following reasons: a. diffuse deep infiltration of the root of small bowel mesentery, or; b. diffuse carcinomatosis of the small bowel that requires resection that leads to short bowel syndrome (remaining bowel <1.5 meter), or; c. diffuse involvement/deep infiltration of stomach/duodenum, or; d. diffuse involvement/deep infiltration of head or middle part of pancreas, or; e. involvement of truncus coeliacus , hepatic arteries or left gastric artery, or; f. non-resectable enlarged (larger than 10 mm short axis) lymph nodes\n- in case of a known psychiatric disorder, substance abuse disorder, or high suspicion of a mental disorder that could interfere with cooperation or compliance with the requirements of the trial\n- when opting for fertility sparing surgery, or when breastfeeding\n- in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2 antibodies)\n- in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])\n- patients who received prior treatment for the current malignancy"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is overall survival, defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (“last known alive date”). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up.","definition_or_measurement_approach":"Defined as time from randomization to date of death from any cause; alive subjects censored at date of last contact (“last known alive date”); subjects randomized with no follow-up censored at date of randomization."}

Secondary endpoints

• {"endpoint_text":"- Recurrence-free survival is defined as the time between the date of randomization and the first date of documented disease progression or recurrence, as determined by the GCIG criteria (Appendix 1) , or death due to any cause, whichever occurs first (36). Disease recurrence or progression will be regularly evaluated via a standardized follow-up scheme and/or following clinical symptoms.","definition_or_measurement_approach":"Time from randomization to first documented disease progression or recurrence per GCIG criteria, or death from any cause; regular evaluation via standardized follow-up and/or clinical symptoms."}
• {"endpoint_text":"- The time to first subsequent anticancer treatment after first recurrent disease (TFST)","definition_or_measurement_approach":"Time from first recurrence to initiation of first subsequent anticancer treatment after that recurrence (TFST)."}
• {"endpoint_text":"- The toxicity and morbidity will be reported until 30 days after the end of chemotherapy, using the Common Toxicity Criteria for Adverse Events (CTCAE v5.0) for all events, and using the Clavien-Dindo method for surgery-related events.","definition_or_measurement_approach":"Adverse events graded by CTCAE v5.0 until 30 days after end of chemotherapy; surgery-related events graded by Clavien-Dindo method."}

Ireland

Latest Decision Or Authorization Date

29-04-2024

Number Of Sites

1

Number Of Participants

12

France

Latest Decision Or Authorization Date

06-05-2024

Number Of Sites

10

Number Of Participants

105

Italy

Latest Decision Or Authorization Date

13-05-2024

Number Of Sites

3

Number Of Participants

138

Sweden

Latest Decision Or Authorization Date

03-05-2024

Number Of Sites

1

Number Of Participants

35

Denmark

Latest Decision Or Authorization Date

29-04-2024

Number Of Sites

3

Number Of Participants

50

Germany

Latest Decision Or Authorization Date

09-10-2024

Number Of Sites

1

Number Of Participants

10

Netherlands

Latest Decision Or Authorization Date

03-05-2024

Number Of Sites

10

Number Of Participants

135

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"The Dutch Cancer Society (KWF)","duties_or_roles":"Monetary support","organisation_type":""}