ICON8: An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer

Short title

ICON8 (Australia New Zealand Gynaecological Oncology Group trial number ANZGOG14)

Summary

ICON8 is a randomised (1:1:1 ratio), three-arm, three stage Gynaecologic Cancer InterGroup (GCIG) phase III trial designed to evaluate the safety and efficacy of dose-dense, dose-fractionated carboplatin-paclitaxel chemotherapy in the first-line treatment of ovarian cancer.

Official title

An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.

Status

Currently Recruiting

Conditions

Ovarian, peritoneal or fallopian tube cancers

Intervention

Dose-dense, dose-fractionated carboplatin-paclitaxel

Phase

Phase III

Study type

Interventional

Study design

Allocation” Randomised (1:1:1 ratio), three-arm, three stage GCIG phase III trial.
Endpoint: Safety/Efficacy
Intervention: Dose-dense, dose fractionated carboplatin paclitaxel
Primary Purpose: Treatment

Study start –> end dates

July 2014 – October 2014

Eligibility and criteria

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

• Age: > 18 years
• Patients over the age of 18 with histologically confirmed, with core biopsy from a disease site as minimum requirement:
  • Epithelial ovarian carcinoma
  • Primary peritoneal carcinoma of Mullerian histological type
  • Fallopian tube carcinoma
  • Ovarian carcinosarcoma
• FIGO State IC or above (see protocol)
• ECOG PS 0-2
• Life expectancy > 12 weeks
• Adequate bone marrow function, liver function and renal function (see protocol)
• Able to start chemotherapy within 8 weeks after immediate primary surgery (where applicable)

Women will be eligible for inclusion following immediate primary surgery, while awaiting delayed primary surgery planned and while awaiting delayed primary surgery. Women with inoperable stage III/IV disease at diagnosis and those who have not received surgical treatment may also be eligible to participate in the trial.

Total enrolment

Tbc

Contact

Principal Investigator Dr Andrew Dean, St John of God Hospital, Subiaco WA.

NSW – Bankstown Hospital
Dr Sandra Harvey

NSW – University of Newcastle
Dr Janine Lombard

NSW – St George Hospital
Dr Jodi Lynch

NSW – Westmead Clinical School (University of Sydney)
Dr Alison Brand
Associate Professor Paul Harnett
Dr Gerard Wain

QLD – Townsville Cancer Centre
Dr Abhishek Joshi

VIC – Ballarat Health Services
Dr Stephen Brown

VIC – Mercy Hospital for Women
Dr Serene Foo

VIC – Monash Cancer Centre
Dr Geraldine Goss

VIC – Royal Women’s Hospital
Dr Vivek Arora
Prof Michael Quinn

WA – Sir Charles Gairdner Hospital
Dr Martin Buck
Dr Tarek Meniawy

WA – St John of God Hospital, Subiaco
Dr Andrew Dean
Dr Martin Buck
Dr Raj Mohen
Dr Stuart Salfinger
Dr Jason Tan

ICON8 Trial Participating Institutions