Ovarian Cancer Clinical Trial
Official title:
A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells.
It is not yet known whether chemotherapy before surgery is more effective than chemotherapy
after surgery in treating ovarian, peritoneal, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to
see how well it works compared to chemotherapy given after surgery with or without
additional surgery in treating patients with stage III or stage IV ovarian cancer,
peritoneal cancer, or fallopian tube cancer.
OBJECTIVES:
- 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
surgery.
- 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
annually thereafter.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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