SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers
- Compare progression-free survival of patients with stage IC-IV ovarian epithelial,
fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient
dose-escalated carboplatin as first-line chemotherapy.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare overall clinical response rate and CA 125 response in patients treated with
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients receive a flat dose of carboplatin on day 1.
- Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both
arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, before each treatment course, and then at 2 months
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months
for 1 year, and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for
Allocation: Randomized, Primary Purpose: Treatment
Stanley B. Kaye, MD, FRCP
Royal Marsden NHS Foundation Trust
United States: Federal Government