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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival at 3 years
No
Sean Kehoe
Principal Investigator
Oxford Radcliffe Hospital
Unspecified
CDR0000347463
NCT00075712
September 2003
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