Trial Information

Assessing Economic Outcomes in Women With Stage III Ovarian Cancer Treated With Intravenous Paclitaxel and Cisplatin v. Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel on GOG #172: A Feasibility Study of Assessing Costs and Medical Resource Use

OBJECTIVES:

- Determine the feasibility of collecting data on medical resource utilization and costs
incurred in the care of patients with stage III ovarian cancer treated with intravenous
(IV) paclitaxel and cisplatin vs IV paclitaxel, intraperitoneal (IP) paclitaxel, and IP
cisplatin on a randomized, controlled clinical trial.

- Determine the feasibility of collecting data on resource utilization incurred outside
GOG institutions through the use of patient diaries.

- Assess the work load required to collect this data, in terms of mean number of hours
required to complete medical resource utilization forms.

OUTLINE: Data on medical resource units consumed (including length of hospital stay, length
of time using operating room, units of drugs and blood products administered, number of
diagnostic tests received, and number of physician visits needed) are collected on all
patients.

Quality of life is assessed prior to randomization on clinical trial GOG-172, prior to the
fourth course of chemotherapy, after the sixth course of chemotherapy, and at 3 months and 6
months after the sixth course of chemotherapy. Patients complete diaries throughout
treatment with chemotherapy and for 12 months after treatment.

Data collected are used for analysis of economic impact, quality of life, neurotoxicity, and
sociologic characteristics associated with these treatment regimens.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.