Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005583
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2000-05-02
Brief Title:
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
Sponsor:
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2006-11
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 whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer
PURPOSE This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer
PURPOSE This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer
Detailed Description:
OBJECTIVES
Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially
Compare overall survival of this patient population treated with these 2 adjuvant regimens
Evaluate the addition of chemotherapy to standard adjuvant radiotherapy in terms of toxicity in these patients
Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to center and histologic type serous papillary and clear cell vs all other types Patients are randomized to 1 of 2 treatment arms
All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes
Arm I Within 7 weeks after surgery patients begin radiotherapy
Arm II Patients receive radiotherapy followed by or preceded by chemotherapy Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1 Treament repeats every 21 days for 4 courses
NOTE If radiotherapy is preceded by chemotherapy radiotherapy begins within 4 weeks after chemotherapy
Patients are followed at 3 and 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 5 years
Compare relapse-free survival of patients with high-risk endometrial carcinoma treated in the adjuvant setting with either radiotherapy alone or radiotherapy and chemotherapy given sequentially
Compare overall survival of this patient population treated with these 2 adjuvant regimens
Evaluate the addition of chemotherapy to standard adjuvant radiotherapy in terms of toxicity in these patients
Study whether the pattern of relapse in these patients is influenced by the addition of chemotherapy to adjuvant radiotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to center and histologic type serous papillary and clear cell vs all other types Patients are randomized to 1 of 2 treatment arms
All patients undergo hysterectomy with bilateral salpingooophorectomy and extirpation of macroscopic suspicious lymph nodes
Arm I Within 7 weeks after surgery patients begin radiotherapy
Arm II Patients receive radiotherapy followed by or preceded by chemotherapy Patients receive cisplatin IV over 60 minutes and doxorubicin or epirubicin IV over 10-20 minutes on day 1 Treament repeats every 21 days for 4 courses
NOTE If radiotherapy is preceded by chemotherapy radiotherapy begins within 4 weeks after chemotherapy
Patients are followed at 3 and 6 months and then every 6 months for 5 years
PROJECTED ACCRUAL A total of 400 patients 200 per treatment arm will be accrued for this study within 5 years
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-55991 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067646 | REGISTRY | None | None |