A Phase 3 interventional study of TCG and TC in Fallopian Tube Cancer and Ovarian Cancer, sponsored by AGO Study Group. Completed at 17 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by AGO Study Group · Phase 3, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 1,742 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →AGO Study Group is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Ovarian epithelial cancer
The following are ineligible:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except:
Radiotherapy
Surgery
Other
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Drug: TCG
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
Drug: TC
Also known as: Paclitaxel/Carboplatin/Gemcitabine
Also known as: Paclitaxel/Carboplatin
Overall Survival
Survival time is calculated from the date of enrollment into the study until the date of death from any cause
Time frame: Whole Study Period
Progression Free Survival
The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first
Time frame: Whole Study Period
Quality of Life
Time frame: Whole Study Period
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AGO Study Group