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
Medical Research Council
OBJECTIVES: Primary * Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab. Secondary * Compare the response rate in patients treated with these regimens. * Compare the duration of tumor response in patients treated with these regimens. * Compare the biological progression-free interval, as measured by increasing CA 125 levels, in patients treated with these regimens. * Compare the safety (e.g., adverse events, laboratory results, and performance status) of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Compare the cost-effectiveness of these regimens in these patients. OUTLINE: This is a multicenter, open-label, randomized, controlled study. Patients are stratified according to FIGO stage (stage I-III with residual disease ≤ 1 cm vs stage I-III with residual disease \> 1 cm vs stage IV disease), intended time to start chemotherapy after surgery (≤ 4 weeks vs \> 4 weeks), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I (control): Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive bevacizumab IV over 30-90 minutes followed by paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab alone every 3 weeks for 12 courses. Quality of life is assessed at baseline, before every course, every 6 weeks for 1 year, every 3 months until disease progression or for up to 2 years, and then at 3 years. Health economic data is assessed periodically, including days of inpatient hospitalization visits, outpatient visits, and use of anticancer therapies. After completion of study treatment, patients are followed every 3-6 months for 5 years and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
