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Phase III Randomized Study of Neoadjuvant Chemotherapy Followed By Interval Debulking Surgery Versus Upfront Cytoreductive Surgery Followed By Chemotherapy With or Without Interval Debulking Surgery in Patients With Stage IIIC or IV Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Trial Contact Information Related Information Registry Information
Alternate Title
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Closed | Not specified | EORTC-55971 NCT00003636 |
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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery - No other prior procedures except diagnostic
biopsy by laparotomy or laparoscopy
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
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
Expected Enrollment 704A total of 704 patients will be accrued for this study within 4 years. Outcomes Primary Outcome(s)Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
Secondary Outcome(s)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 Health-related quality of life as measured by Quality of Life Questionnaire-C30 after courses 1, 3 and 6, then at 6 and 12 months Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery
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. Published ResultsFruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.
Trial Contact Information
Trial Lead Organizations European Organization for Research and Treatment of Cancer | | | Ignace Vergote, MD, PhD, Study coordinator | | | |
Related Information PDQ® clinical trial CAN-NCIC-OV16
Registry Information | | 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 | | Trial Start Date | | 1998-09-21 | | Registered in ClinicalTrials.gov | | NCT00003636 | | Date Submitted to PDQ | | 1998-10-14 | | Information Last Verified | | 2006-11-19 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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