Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
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.
Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
Progression-free survival as measured by Kaplan Meier and RECIST every 3 months for 2 years, every 6 months for 3 years, and then annually
Fallopian Tube Cancer
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
DISEASE CHARACTERISTICS: - Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma - If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true: - Presence of pelvic ovarian mass - Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis - CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor) - Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25) - Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan - No brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: - Creatinine less than 1.25 times ULN Other: - No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy - No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin - No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy
N/A - N/A
Accepts Healthy Volunteers
Ignace B. Vergote, MD, PhD, ,
European Organisation for Research and Treatment of Cancer - EORTC
Ignace B. Vergote, MD, PhD, Study Chair, U.Z. Gasthuisberg, Leuven