Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005830
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy 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:
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer
II Determine the acute and chronic toxic effects in particular severe and life-threatening gastrointestinal hepatic and hematologic toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin IV and cisplatin IV on day 1 Treatment repeats every 3 weeks for 3 courses Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-53 patients will be accrued for this study within 35 years
I Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer
II Determine the acute and chronic toxic effects in particular severe and life-threatening gastrointestinal hepatic and hematologic toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive doxorubicin IV and cisplatin IV on day 1 Treatment repeats every 3 weeks for 3 courses Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-53 patients will be accrued for this study within 35 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-2012-02332 | REGISTRY | None | None |
| CDR0000067844 | None | None | None |
| GOG-9908 | OTHER | None | None |
| GOG-9908 | OTHER | None | None |