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| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004921 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery | ||||
| Official Title ICMJE | A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for ovarian epithelial cancer. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy, and then at 3 months, 9 months, and 15 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this study. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Mobus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R, Ostermann H, Hinke A, Ledermann JA. High-Dose Sequential Chemotherapy With Peripheral Blood Stem Cell Support Compared With Standard Dose Chemotherapy for First-Line Treatment of Advanced Ovarian Cancer: Results of a Phase III Intergroup Trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol. 2007 Aug 13; [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Belgium, Czech Republic, Germany, Italy, Slovakia, Spain, Switzerland, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004921 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067604, EBMT-HIDOC-EIS, EBMT-OVCAT, EU-99040 | ||||
| Study Sponsor ICMJE | EBMT Solid Tumors Working Party | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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