Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002493
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III
Status:
COMPLETED
Status Verified Date:
2014-02
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 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 It is not yet known which treatment regimen is more effective for endometrial cancer
PURPOSE Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer
PURPOSE Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer
Detailed Description:
OBJECTIVES I Compare overall survival progression-free interval and patterns of failure of maximally debulked patients with stage IIIIV endometrial carcinoma treated with whole-abdominal irradiation vs doxorubicincisplatin II Compare the incidence and type of acute and late adverse events observed with these two treatment regimens III Compare changes in fatigue elimination and neurologic impairment that impact on quality of life in patients treated with these two regimens IV Assess the difference in short-term versus long-term impact on quality of life between the two treatment groups V Compare quality-of-life outcomes over time between these two treatment groups
OUTLINE Randomized study Arm I Radiotherapy Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV Arm II 2-Drug Combination Chemotherapy Doxorubicin DOX NSC-123127 Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL It is anticipated that 355 patients will be entered over 74 years
OUTLINE Randomized study Arm I Radiotherapy Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV Arm II 2-Drug Combination Chemotherapy Doxorubicin DOX NSC-123127 Cisplatin CDDP NSC-119875
PROJECTED ACCRUAL It is anticipated that 355 patients will be entered over 74 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 |
|---|---|---|---|
| CDR0000077572 | None | None | None |