Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
NHS Greater Glasgow and Clyde
OBJECTIVES: Primary * 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. Secondary * 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 these regimens. * Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * 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 post-chemotherapy. 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 this study.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
