A Phase 3 interventional study of Carboplatin and Carboplatin in Ovarian Cancer, sponsored by Medical Research Council. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-31.
Sponsored by Medical Research Council · Phase 3, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 1,485 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Medical Research Council is the lead sponsor of 67 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed, with core biopsy from a disease site as minimum requirement (cytology alone is insufficient for diagnosis):
Confirmed high-risk histological subtype for patients with FIGO stage IC/IIA disease, namely:
Adequate bone marrow function:
Adequate liver function (within 28 days prior to randomisation):
Exclusion Criteria:
Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles
Drug: Carboplatin · Drug: Paclitaxel
Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles
Drug: Carboplatin · Drug: Paclitaxel
Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.
Drug: Carboplatin · Drug: Paclitaxel
AUC5 by intravenous infusion over 30-60 minutes
AUC2 by intravenous infusion over 30-60 minutes
175mg/m2 by intravenous infusion over 3 hours
80mg/m2 by intravenous infusion over 1 hour
Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.
Time frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient.
Time frame: 6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm
Stage 2: Progression Free Survival rate at 9 months after randomisation
Time frame: 9 months after first 62 patients randomised per arm
Stage 3: Progression Free Survival
Time frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
Stage 3: Overall Survival
Time frame: PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.
Stage 3: Toxicity assessed by number of participants with adverse events
Assessment of toxicity profile of dose-fractionated chemotherapy
Time frame: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Quality of Life
Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.
Time frame: Expected 1 year and 3 years after last patient is randomised.
Stage 3: Health Economics
Cost-effectiveness analysis of dose-fractionated chemotherapy
Time frame: Expected 1 year and 3 years after last patient is randomised.
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Medical Research Council