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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003636 |
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.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 704 |
Study Start Date: | September 1998 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Investigator: | Ignace B. Vergote, MD, PhD | U.Z. Gasthuisberg |
Study ID Numbers: | CDR0000066721, EORTC-55971 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003636 |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Dental Caries Genital Diseases, Female Naphazoline Cisplatin Phenylephrine Peritoneal Diseases Phenylpropanolamine Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Oxymetazoline Digestive System Diseases Guaifenesin Gastrointestinal Neoplasms Peritoneal Neoplasms Fallopian tube cancer Endocrinopathy |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Adnexal Diseases |