Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004934
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2000-03-07
Brief Title:
Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB Stage III or Stage IV Invasive Ovarian Epithelial Fallopian Tube or Peritoneal Cancer
Sponsor:
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial of PaclitaxelEpirubicinCarboplatin Combination TEC Versus PaclitaxelCarboplatin TC in the Treatment of Women With Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether receiving paclitaxel and carboplatin with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian epithelial fallopian tube or peritoneal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with or without epirubicin in treating patients who have stage IIB stage III or stage IV invasive ovarian epithelial fallopian tube or peritoneal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with or without epirubicin in treating patients who have stage IIB stage III or stage IV invasive ovarian epithelial fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES
Compare progression free survival and overall survival in patients with stage IIB III or IV invasive ovarian epithelial fallopian tube or peritoneal cancer treated with paclitaxel and carboplatin with or without epirubicin
Compare the toxicity of these 2 regimens in these patients
Compare the quality of life of patients treated with these 2 regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center and type of surgery delayed surgery 3 courses of chemotherapy before surgery vs primary surgery optimally debulked stage IIB or III residual tumor less than 1 cm vs primary surgery suboptimally debulked stage IV residual tumor 1 cm or greater
Surgery
Patients are assigned to one of two surgery groups
Group A Patients undergo primary surgery comprised of hysterectomy bilateral salpingo-oophorectomy BSO omentectomy and resection of all tumor masses if possible before beginning chemotherapy Patients with residual disease greater than 1 cm after completion of primary surgery receive 3 courses of chemotherapy followed within 6 weeks by interval debulking surgery followed within 3 weeks by the fourth course of chemotherapy
Group B Patients undergo delayed surgery comprised of hysterectomy BSO omentectomy and resection of all tumor masses if possible after completion of 3 courses of chemotherapy
Chemotherapy
Patients are randomized to 1 of 2 chemotherapy arms
Arm I Patients receive epirubicin IV over 15-20 minutes paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 6 courses Patients with residual tumor after completion of 6 courses may receive 3 additional courses
Arm II Patients receive paclitaxel and carboplatin as above but no epirubicin Quality of life is assessed before beginning study after completion of courses 3 6 and 9 if applicable and then at 6 and 12 months after completion of study treatment
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study
Compare progression free survival and overall survival in patients with stage IIB III or IV invasive ovarian epithelial fallopian tube or peritoneal cancer treated with paclitaxel and carboplatin with or without epirubicin
Compare the toxicity of these 2 regimens in these patients
Compare the quality of life of patients treated with these 2 regimens
OUTLINE This is a randomized multicenter study Patients are stratified by center and type of surgery delayed surgery 3 courses of chemotherapy before surgery vs primary surgery optimally debulked stage IIB or III residual tumor less than 1 cm vs primary surgery suboptimally debulked stage IV residual tumor 1 cm or greater
Surgery
Patients are assigned to one of two surgery groups
Group A Patients undergo primary surgery comprised of hysterectomy bilateral salpingo-oophorectomy BSO omentectomy and resection of all tumor masses if possible before beginning chemotherapy Patients with residual disease greater than 1 cm after completion of primary surgery receive 3 courses of chemotherapy followed within 6 weeks by interval debulking surgery followed within 3 weeks by the fourth course of chemotherapy
Group B Patients undergo delayed surgery comprised of hysterectomy BSO omentectomy and resection of all tumor masses if possible after completion of 3 courses of chemotherapy
Chemotherapy
Patients are randomized to 1 of 2 chemotherapy arms
Arm I Patients receive epirubicin IV over 15-20 minutes paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 6 courses Patients with residual tumor after completion of 6 courses may receive 3 additional courses
Arm II Patients receive paclitaxel and carboplatin as above but no epirubicin Quality of life is assessed before beginning study after completion of courses 3 6 and 9 if applicable and then at 6 and 12 months after completion of study treatment
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-55981 | None | None | None |
| NSGO-OC9804 | None | None | None |
| CAN-NCIC-OV14 | None | None | None |