ICON8: Weekly Chemotherapy in Ovarian Cancer v1.0

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  64812

• Contact name

  Andrew Clamp

• Sponsor organisation

  MRC Clinical Trials Unit

• Eudract number

  2010-022209-16

• ISRCTN Number

  pending

• Research summary

  Ovarian cancer is the most lethal gynaecological malignancy in the UK. Most patients respond well to first-line treatment, surgery and chemotherapy, but the majority go on to develop relapsed disease and the 5-year survival rate for patients with advanced disease is only 30%. There is a significant need to develop more effective first-line treatments. Standard first-line chemotherapy is a combination of two drugs: carboplatin and paclitaxel, given once every 3 weeks for 6 cycles. However, giving these agents weekly may be more effective; this is called dose-fractionated chemotherapy. In ICON8 two dose-fractionated chemotherapy regimens are compared with standard carboplatin-paclitaxel. The main outcome measures are whether dose-fractionated chemotherapy extends the time until ovarian cancer relapses (improved progression-free survival) and whether women who receive it live longer (improved overall survival). Secondary outcome measures are comparative toxicity, impact on quality of life and cost-effectiveness. Two interim analyses are planned: the first looking at feasibility and safety of the dose-fractionated regimens; and the second at their activity. Women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancers are eligible; including those with high-risk early stage (FIGO IC/IIA) or advanced (FIGO IIB-IV) cancers. They can enter the trial either following primary surgery or with a plan to undergo delayed primary surgery between the 3rd and 4th cycles of chemotherapy. Women will be randomised to receive either: standard chemotherapy; or carboplatin given 3-weekly with weekly paclitaxel; or both carboplatin and paclitaxel weekly. Treatment duration in all three arms is 18 weeks. ICON8 will be conducted in NHS cancer units and centres throughout the UK. Target accrual is 1485 women over 3 years. Follow-up will continue until progression or up to 6 years. Progression-free survival data is expected to be mature 4 years after the trial opens and overall survival data 2 years later.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0043

• Date of REC Opinion

  8 Apr 2011

• REC opinion

  Further Information Favourable Opinion