Trial Outcomes & Findings for Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus (NCT NCT00231842)
NCT ID: NCT00231842
Last Updated: 2019-01-23
Results Overview
Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years
Results posted on
2019-01-23
Participant Flow
Eligible participants with surgically staged I-IV uterine carcinosarcoma (CS) without evidence of gross residual disease after primary surgery were recruited from 1999 to 2009 . Eligible participants underwent surgical staging when clinically indicated.
30 participants were enrolled and 3 participants withdrew prior to therapy. Twenty-seven participants received the first three cycles of chemotherapy and Radiation Therapy and were included in the analysis.
Participant milestones
| Measure |
Chemotherapy and Radiation Therapy
Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
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|---|---|
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Overall Study
STARTED
|
30
|
|
Overall Study
Initiated Therapy
|
27
|
|
Overall Study
Completed First 3 Cycles
|
27
|
|
Overall Study
Completed Prescribed RT
|
27
|
|
Overall Study
Completed Full Prescribed Therapy
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Chemotherapy and Radiation Therapy
Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
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Overall Study
Did not complete the last 3 cycle
|
8
|
Baseline Characteristics
Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
Baseline characteristics by cohort
| Measure |
Chemotherapy and Radiation Therapy
n=27 Participants
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
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.
Ifosfamide : 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.
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|---|---|
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Age, Continuous
|
65 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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27 participants
n=5 Participants
|
|
FIGO Staging
Total Stage I
|
14 Participants
n=5 Participants
|
|
FIGO Staging
Total Stage II
|
3 Participants
n=5 Participants
|
|
FIGO Staging
Total Stage III
|
7 Participants
n=5 Participants
|
|
FIGO Staging
Total Stage IV
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOut of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.
Outcome measures
| Measure |
Grade 3 Toxicity
n=27 Participants
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
Ifosfamide: 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.
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.
|
Grade 4 Toxicity
n=27 Participants
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
Ifosfamide: 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.
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|---|---|---|
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Cycles With Hematologic Toxicities
Anemia
|
6 Cycles
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0 Cycles
|
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Cycles With Hematologic Toxicities
Neutropenia
|
11 Cycles
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14 Cycles
|
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Cycles With Hematologic Toxicities
Thrombocytopenia
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6 Cycles
|
2 Cycles
|
Adverse Events
Chemotherapy and Radiation Therapy
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy and Radiation Therapy
n=27 participants at risk
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
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.
Ifosfamide : 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.
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|---|---|
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Blood and lymphatic system disorders
Neutropenia
|
48.1%
13/27 • Participants were followed up to 2 years.
Adverse events were monitored for each cycle during therapy and during follow-up and graded using the National Cancer Institute Common Toxicity Criteria (CTC) version 3.0. Frequencies for toxicity and adverse events were recorded. Although adverse events were monitored, however, not all adverse events are being reported. The PI and the study team have left the institution. Sincere efforts were made to obtain the data, however, the adverse events data is not available.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place