Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
European Organisation for Research and Treatment of Cancer - EORTC
OBJECTIVES: * Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery. * Determine the toxicity of these treatment regimens in these patients. * Determine the complications related to surgical treatment in these patients. * Compare the quality of life in these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center. Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms. * Arm I: Patients undergo secondary cytoreductive surgery within 14 days of randomization. Within 8 weeks after the last preoperative chemotherapy course, patients continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses as in arm I. Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1 week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up to 5 years. Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression. PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
