Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006011
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2000-07-05
Brief Title:
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer
Detailed Description:
OBJECTIVES
I Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel
II Compare short and long-term toxic effects of these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to radiotherapy field pelvic vs extended field Within 8 weeks after surgery patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery Within 8 weeks of completing radiotherapy patients are randomized to 1 of 2 chemotherapy treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously SC or pegfilgrastim on days 2-11
Arm II Patients receive doxorubicin and cisplatin as in arm I paclitaxel IV over 3 hours on day 2 and G-CSF SC or pegfilgrastim on days 3-12 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 614 patients 307 per treatment arm will be accrued for this study within 52 years
I Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel
II Compare short and long-term toxic effects of these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to radiotherapy field pelvic vs extended field Within 8 weeks after surgery patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery Within 8 weeks of completing radiotherapy patients are randomized to 1 of 2 chemotherapy treatment arms
Arm I Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1 Patients also receive filgrastim G-CSF subcutaneously SC or pegfilgrastim on days 2-11
Arm II Patients receive doxorubicin and cisplatin as in arm I paclitaxel IV over 3 hours on day 2 and G-CSF SC or pegfilgrastim on days 3-12 Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 614 patients 307 per treatment arm will be accrued for this study within 52 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02350 | REGISTRY | None | None |
| ECOG-G0184 | None | None | None |
| RTOG-EN0130 | None | None | None |
| CDR0000068020 | None | None | None |
| GOG-0184 | OTHER | None | None |
| GOG-0184 | OTHER | None | None |