NCT00098878

Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	carboplatin

Timeline

• Start date: 2004-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2004-12-09
• Last updated: 2013-08-07

Locations

88 sites across 3 countries: Australia, New Zealand, United Kingdom