NCT01654146

ICON8: Weekly Chemotherapy in Ovarian Cancer

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,485 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.

Detailed description

ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio. Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility and safety of protocol treatment in all patients and separately in the Delayed Primary Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then the research arms will be reconsidered.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC5 by intravenous infusion over 30-60 minutes
DRUG	Carboplatin	AUC2 by intravenous infusion over 30-60 minutes
DRUG	Paclitaxel	175mg/m2 by intravenous infusion over 3 hours
DRUG	Paclitaxel	80mg/m2 by intravenous infusion over 1 hour

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-06-01
• First posted: 2012-07-31
• Last updated: 2012-07-31

Locations

1 site across 1 country: United Kingdom