A Phase II Trial of Adjuvant Radiation Therapy With Ifosfamide in Patients With MMT of the Uterus
The optimal sequence and /or modality for adjuvant therapy in the management of MMT clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.
The concept of sequential chemotherapy/radiation therapy/chemotherapy has been previously reported. The chemotherapeutic agents employed in that trial were cisplatin and epirubicin with a reported survival of 74% in patients with Stage I and II MMT with a median follow-up period of 55 months. Toxicity was reported as tolerable and 98% of patients were able to complete their therapy. Sequential chemotherapy/radiation/chemotherapy has also been investigated in other high risk uterine tumors with a propensity for both distant and local recurrence. A retrospective review of 23 patients treated with radiation "sandwiched" between paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinomas found 5/23 (22%) to have recurred with a median PFI of 16.6 months (range 12.1 - 23 months). The median follow-up was 21 months (range 10-45 months). Of the patients remaining disease-free, the median PFI was 21.4 months (range 10-15 months). Toxicity was acceptable and the regimen was well tolerated. A prospective trial of this regimen is presently ongoing and without unexpected toxicity or morbidity.
The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date (ifosfamide/cisplatin). 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Trial of Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors|
- To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of chemotherapy in patients with MMT. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To define patterns of recurrence and one-year recurrence-free survival in patients with MMT treated with "sandwich" therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.Procedure: Radiation Therapy
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.
Other Name: Pelvic RT, Radiation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00231842
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Mark H Einstein, M.D., M.S.||Montefiore Medical Center and Albert Einstein College of Medicine|