ICON8 Eligibility criteria

Patients recruited onto the ICON8 trial were required to meet the following criteria:

Patient inclusion criteria

  1. Females aged ≥18 years
  2. Signed informed consent and ability to comply with the protocol
  3. Histologically confirmed, with core biopsy from a disease site as minimum requirement (cytology alone is insufficient for diagnosis)

    Epithelial ovarian carcinoma
    Primary peritoneal carcinoma of Müllerian histological type
    Fallopian tube carcinoma
  4. FIGO stage IC or above, which may be based on clinical and radiological assessment in patients who have not undergone immediate primary surgery
  5. Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease, namely:

    High grade serous carcinoma
    Clear cell carcinoma
    Other histological subtype considered poorly differentiated/grade 3
  6. ECOG Performance Status (PS) 0-2
  7. Life expectancy >12 weeks
  8. Adequate bone marrow function:

    Absolute Neutrophil Count (ANC) ≥1.5 x 109/l
    Platelets (Plt) ≥100 x 109/l
    Haemoglobin (Hb) ≥9g/dl (can be post transfusion)
  9. Adequate liver function (within 28 days prior to randomisation):

    Serum bilirubin (BR) ≤1.5 x ULN
    Serum transaminases ≤3 x ULN in the absence of parenchymal liver metastases or ≤5 x ULN in the presence of parenchymal liver metastases
  10. Adequate renal function as defined by:
    • Directly measured GFR (Glomerular Filtration Rate) ≥30ml/min, or
    • Calculated creatinine clearance ≥60ml/min*
  11. Able to start chemotherapy within 8 weeks after immediate primary surgery (where applicable)

*Direct measurement of GFR by a radioisotope method is highly recommended in all cases but it is acceptable for GFR to be measured or calculated according to local practice (see Appendix 4). However, if the calculated creatinine clearance is <60ml/min then it is mandatory that a formal measurement of the GFR is performed (using either a 24 hour urine collection or an isotopic clearance)

Patient exclusion criteria

  1. Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours (carcinosarcomas)
  2. Peritoneal cancer that is not of Müllerian origin, including mucinous histology
  3. Borderline tumours (tumours of low malignant potential)
  4. Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
  5. Previous malignancies within 5 years prior to randomisation apart from: adequately treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ, non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no lymphovascular space invasion
  6. Pre-existing sensory or motor neuropathy grade ≥2
  7. Evidence of any other disease/metabolic dysfunction that in the opinion of the investigator would put the subject at high-risk of treatment-related complications or prevent compliance with the trial protocol
  8. Planned intraperitoneal cytotoxic chemotherapy
  9. Planned maintenance treatment with systemic anti-cancer therapy following completion of protocol treatment and prior to protocol defined progression
  10. Any previous radiotherapy to the abdomen or pelvis
  11. Sexually active women of childbearing potential not willing to use adequate contraception (eg. oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
  12. Pregnant or lactating women
  13. Treatment with any other investigational agent prior to protocol defined progression
  14. Known hypersensitivity to carboplatin, paclitaxel or their excipients (including cremophor)
  15. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with brain or meningeal metastases are not eligible



MRC Clinical Trials Unit at UCL
90 High Holborn 

ICON8 and ICON8B: mrcctu.icon8and8b@ucl.ac.uk