Ovarian Cancer Clinical Trial
Official title:
A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
the tumor so that it can be removed; giving chemotherapy after surgery may kill any
remaining tumor cells. It is not yet known whether giving chemotherapy before and after
surgery is more effective than giving chemotherapy after surgery in treating ovarian
epithelial, fallopian tube, or primary peritoneal cavity cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before
and after surgery works and compares it to giving chemotherapy after surgery alone in
treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or
primary peritoneal cavity cancer.
OBJECTIVES:
- Determine the feasibility of a randomized trial to determine the impact of the timing
of surgery and chemotherapy in patients with newly diagnosed advanced ovarian
epithelial, primary peritoneal, or fallopian tube cancer.
OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary
surgery, patients receive chemotherapy comprising carboplatin alone or in combination
with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3
weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients may undergo interval debulking surgery after the third course of
chemotherapy.
- Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3
courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6
weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm
I.
Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18
months.
;
Allocation: Randomized, Primary Purpose: Treatment
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