Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Received Date † | January 24, 2003 | ||||||||||||
Last Updated Date | February 6, 2009 | ||||||||||||
Start Date † | August 2002 | ||||||||||||
Current Primary Outcome Measures † | |||||||||||||
Original Primary Outcome Measures † | |||||||||||||
Change History | Complete list of historical versions of study NCT00052468 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † | |||||||||||||
Original Secondary Outcome Measures † | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer | ||||||||||||
Official Title † | A Multi-National Randomized Phase III GCIG Intergroup Study Comparing 1st Line Chemotherapy With Gemcitabine, Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV | ||||||||||||
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 whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer. |
||||||||||||
Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
Some patients undergo interval debulking surgery. Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years. |
||||||||||||
Study Phase | Phase III | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control | ||||||||||||
Condition † |
|
||||||||||||
Intervention † |
|
||||||||||||
Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | |||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||||||||||
Gender | Female | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | Denmark, France, Germany, Norway | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00052468 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | AGO-OVAR-9, NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241 | ||||||||||||
Study Sponsor † | AGO Ovarian Cancer Study Group | ||||||||||||
Collaborators †† |
|
||||||||||||
Investigators † |
|
||||||||||||
Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | January 2008 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |