A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
- Compare the overall survival and progression-free survival in patients with stage IIIC
or IV ovarian epithelial, peritoneal, or fallopian tube carcinoma treated with
neoadjuvant chemotherapy followed by interval debulking surgery versus upfront
cytoreductive surgery followed by chemotherapy with or without interval debulking
- Compare the quality of life of patients treated with these regimens.
- Compare the different treatment complications in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, method of biopsy, stage, largest tumor size before surgery, and intent
to also randomize on EORTC-55012. Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or
carboplatin IV every 3 weeks for 3 courses. Patients with non-optimal primary debulking
may undergo interval debulking surgery at the physician's discretion. All patients then
receive an additional 3 courses of the same regimen of chemotherapy.
- Arm II: Patients receive chemotherapy as in arm I. Patients with stable or responding
disease undergo interval debulking surgery followed by an additional 3 courses of the
same regimen of chemotherapy.
Second-look surgery is allowed for both arms if clinically indicated.
Quality of life (QOL) is assessed prior to treatment, after the third and sixth course of
chemotherapy, and at 6 and 12 months after study. Patients who are also randomized on
EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.
Allocation: Randomized, Primary Purpose: Treatment
Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
Ignace B. Vergote, MD, PhD
U.Z. Gasthuisberg, Leuven
United States: Federal Government