Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492778
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-29
First Post:
2007-06-25
Brief Title:
Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
Sponsor:
GOG Foundation
Organization:
GOG Foundation
Study Overview
Official Title:
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina
SECONDARY OBJECTIVES
I To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma
II To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin
III To estimate the prognostic significance of the location central pelvis versus vagina and size of the recurrence in addition to the prognostic significance in the salvage setting of the histological subtype grade patient age race performance status and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy
IV To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo external-beam radiotherapy EBRT to the pelvis daily on days 1-5 for 5 weeks After completion of EBRT patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy
ARM II Patients undergo EBRT as in Arm I and receive cisplatin intravenously IV over 1-2 hours on days 1 8 15 22 and 29 Patients then undergo brachytherapy as in Arm I
NOTE IMRT boost is allowed for patients who are not candidates for brachytherapy IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis andor the boost in patients not undergoing brachytherapy In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every month for 3 months 3 months for 2 years and then every 6 months for 3 years
I To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina
SECONDARY OBJECTIVES
I To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma
II To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin
III To estimate the prognostic significance of the location central pelvis versus vagina and size of the recurrence in addition to the prognostic significance in the salvage setting of the histological subtype grade patient age race performance status and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy
IV To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo external-beam radiotherapy EBRT to the pelvis daily on days 1-5 for 5 weeks After completion of EBRT patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy
ARM II Patients undergo EBRT as in Arm I and receive cisplatin intravenously IV over 1-2 hours on days 1 8 15 22 and 29 Patients then undergo brachytherapy as in Arm I
NOTE IMRT boost is allowed for patients who are not candidates for brachytherapy IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis andor the boost in patients not undergoing brachytherapy In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every month for 3 months 3 months for 2 years and then every 6 months for 3 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-2009-00603 | REGISTRY | None | None |
| CDR0000550975 | None | None | None |
| GOG-0238 | None | None | None |
| GOG-0238 | OTHER | None | None |
| GOG-0238 | OTHER | None | None |
| U10CA180868 | NIH | None | None |