Ovarian Cancer Clinical Trial
Official title:
A Randomised Trial of Interval Debulking Surgery in Epithelial Ovarian Cancer Suboptimally Debulked at Primary Surgery
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells.
It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy
alone in treating patients with stage II or stage III ovarian cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or
without surgery in treating patients with stage II or stage III ovarian cancer.
OBJECTIVES: I. Determine the impact of interval debulking surgery, in terms of survival,
disease-free survival, and quality of life, in patients with newly diagnosed stage II or III
ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery.
OUTLINE: This is a randomized study of debulking surgery with concurrent chemotherapy.
Patients are randomized to receive chemotherapy alone (arm I) or chemotherapy and interval
debulking surgery (arm II). Arm I: Patients receive six courses of platinum-based
chemotherapy at intervals of 3 weeks. Arm II: Patients receive three courses of
platinum-based chemotherapy at intervals of 3 weeks. In the absence of disease progression,
patients undergo interval debulking surgery approximately 21 days after initiation of the
third course of chemotherapy. Surgery is then immediately followed by three additional
courses of platinum-based chemotherapy. Patients are followed at 6 months after
randomization, then every 3 months for the remainder of the first 2 years, then every 6
months for the following 3 years, and then annually thereafter. Quality of life is assessed
prior to randomization and before the fourth course of chemotherapy, and then at follow-up
visits at 6 months and 1, 2, and 3 years.
PROJECTED ACCRUAL: There will be 1,000 patients accrued into this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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