Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231842
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2005-10-03
Brief Title:
Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Pilot Phase II Trial of Adjuvant Radiation Therapy Sandwiched Between Ifosfamide in Patients With Mixed Mesodermal Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The optimal sequence and or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors MMT clearly remains to be established The rationale for the protocol is to sandwich pelvic radiation with chemotherapy to decrease distant metastasis
The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date ifosfamidecisplatin By doing so we attempt to decrease both local and distant recurrence which may translate into an improved progression free interval and possibly even extend survival
The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date ifosfamidecisplatin By doing so we attempt to decrease both local and distant recurrence which may translate into an improved progression free interval and possibly even extend survival
Detailed Description:
Uterine sarcomas account for only 2-4 of uterine malignancies yet they are responsible for 26 of uterine cancer deaths Mixed mesodermal tumors MMT previously known as carcinosarcoma are the most common of the uterine sarcomas in the United States Prognosis for these patients is generally grim due to the propensity for early metastatic disease Patterns of spread are by both hematogenous and lymphatic dissemination It has been noted that 66 of patients with disease clinically confined to the uterus have nodal metastasis at the time of diagnosis The majority of patients will die with both wide spread intra-abdominal and pelvic disease within two years of diagnosis
Adjuvant pelvic radiation therapy has been advantageous in controlling local recurrence One study reports 26 local recurrence in patients treated with surgery alone versus 14 recurrence in patients treated with surgery and adjuvant pelvic radiation Although adjuvant radiation shows a benefit in improving local control it has not been found to impact survival This finding is likely attributed to the high incidence of distant metastasis 85 known to occur with disease recurrence
Multiple chemotherapeutic agents have been evaluated in the management of advanced persistent or recurrent uterine MMT Response to single agent therapy has been less than 35 with the most active agents identified being ifosfamide response rate 348 and cisplatin response rate 179 The use of chemotherapy in the adjuvant setting has been explored as a means of attempting to impact the incidence of distant metastasis
Adjuvant pelvic radiation therapy has been advantageous in controlling local recurrence One study reports 26 local recurrence in patients treated with surgery alone versus 14 recurrence in patients treated with surgery and adjuvant pelvic radiation Although adjuvant radiation shows a benefit in improving local control it has not been found to impact survival This finding is likely attributed to the high incidence of distant metastasis 85 known to occur with disease recurrence
Multiple chemotherapeutic agents have been evaluated in the management of advanced persistent or recurrent uterine MMT Response to single agent therapy has been less than 35 with the most active agents identified being ifosfamide response rate 348 and cisplatin response rate 179 The use of chemotherapy in the adjuvant setting has been explored as a means of attempting to impact the incidence of distant metastasis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None