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. 2021 Apr 2;6(2):100098. doi: 10.1016/j.esmoop.2021.100098

Appendix.

Inclusion and exclusion criteria

Inclusion criteria
PRE-ELIGIBILITY CRITERIA TO BE CHECKED BEFORE SURGERY FOR PRE-REGISTRATION
Age ≥18 years and ≤76 years
HISTOLOGICALLY PROVEN PRIMARY EPITHELIAL OVARIAN CARCINOMA OR FALLOPIAN TUBE CARCINOMA OR PERITONEAL CARCINOMA (INCLUDING SEROUS PAPILLARY ADENOCARCINOMA, CLEAR-CELL CARCINOMA, MUCINOUS ADENOCARCINOMA AND ENDOMETRIOID CARCINOMA). IN CASE OF PRIMARY DEBULKING SURGERY, THE PATIENT CAN BE INCLUDED BASED ON AN EXTEMPORANEOUS DIAGNOSIS OF STAGE III INVASIVE CARCINOMA.
FIGO stage III
Patient eligible for:
  • Primary cytoreductive surgery (PCS) with planned adjuvant chemotherapy with or without bevacizumab or other targeted therapy

  • Interval cytoreductive surgery (ICS) after neoadjuvant chemotherapy with or without bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy with or without bevacizumab or other targeted therapy.

World Health Organization (WHO) performance status ≤2
PHYSICAL STATUS SCORE: AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) SCORE ≤2 or 3 if only related to a body mass index ≥40 KG/M2 OR TO MALIGNANT ASCITES
Adequate bone marrow and renal function, as evidenced by the following tests carried out within 7 days prior to surgery:
  • ABSOLUTE NEUTROPHIL COUNT ≥1500/MM3

  • PLATELET COUNT ≥100 000/MM3

  • Aspartate amino transferase/alanine amino transferase ≤2.5 ULN (upper limit of normal) – (≤5.0 ULN in case of liver metastases)

  • Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease)

  • Creatinine clearance ≥60 ml/min

Negative serum pregnancy test within 7 days prior to surgery for women of childbearing age.
ABSENCE OF CONTRAINDICATION TO RECEIVE THE PRODUCTS USED IN THIS STUDY (CISPLATIN AND PRODUCTS USED IN NEOADJUVANT/ADJUVANT CHEMOTHERAPY) ACCORDING TO THE MOST RECENT SUMMARY OF PRODUCT CHARACTERISTICS OF THESE PRODUCTS13
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
Signed, institutional review board-approved written informed consent
CRITERIA TO BE CHECKED PREOPERATIVELY FOR CONFIRMATION OF ENROLLMENT AND RANDOMIZATION
Residual disease after surgery CC0 (no macroscopic residue) or CC1 (residue < 2.5 mm)
Preoperative hemorrhage < 2.5 l
Strictly less than three digestive resections (other than appendectomy) carried out during surgery (a maximum of three digestive tract anastomosis).
Diuresis during surgery ≥1 ml/kg/h
Exclusion criteria
Benign disease, borderline disease, non-epithelial ovarian carcinoma or carcinosarcoma
Cirrhosis
Known hypersensitivity to any of the study drugs, study drug classes or excipients in the formulation
AUDITORY IMPAIRMENT (I.E. IF HEARING AID IS FITTED OR IF THE PATIENT IS COMPLAINING. IN CASES OF DOUBT, AN AUDIOGRAM SHOULD BE CARRIED OUT.)
Dehydration or intercurrent disease that contraindicates hyperhydration (including cardiorespiratory disease)
Other uncontrolled intercurrent disease including, but not limited to, diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease
ANY UNRESOLVED NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (NCI-CTCAE) GRADE ≥2 TOXICITY FROM PREVIOUS ANTICANCER THERAPY
Concomitant treatment with prophylactic phenytoin
Patients who received live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment)
Pregnant or breastfeeding woman
Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side-effects or compromise the ability of the patient to give written informed consent
Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Person under guardianship or curatorship