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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006356 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: cisplatin Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months |
| Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center.
Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms.
Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1 week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up to 5 years.
Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression.
PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin
Measurable disease by clinical exam or diagnostic laparoscopy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations More Information
| Study ID Numbers: | CDR0000068224, EORTC-55963 |
| Study First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006356 |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer |
|
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases |
Ovarian epithelial cancer Recurrence Genital Diseases, Female Cisplatin Neoplasm Metastasis Endocrinopathy Endocrine Gland Neoplasms |
|
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Adnexal Diseases |
