Participant flow

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer · Source last updated 2021-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

   id

   FG000

   title

   Regimen I - Uterine Carcinsarcoma Subjects

2. description

   Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6

   id

   FG001

   title

   Regimen II - Uterine Carcinsarcoma Subjects

3. description

   Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

   id

   FG002

   title

   Regimen III - Non-uterine Carcinsarcoma Subjects

4. description

   Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6

   id

   FG003

   title

   Regimen IV - Non-uterine Carcinsarcoma Subjects

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         23

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         9

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         22

      3. group Id

         FG002

         num Subjects

         8

      4. group Id

         FG003

         num Subjects

         6

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         3

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Medical Reason

   6. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         47

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         4

      type

      Ineligible

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         3

      type

      Never Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         268

      3. group Id

         FG002

         num Subjects

         51

      4. group Id

         FG003

         num Subjects

         50

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         145

      3. group Id

         FG002

         num Subjects

         27

      4. group Id

         FG003

         num Subjects

         25

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         126

      2. group Id

         FG001

         num Subjects

         123

      3. group Id

         FG002

         num Subjects

         24

      4. group Id

         FG003

         num Subjects

         25

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 637 subjects were enrolled between 08/17/2009 and 3/24/14. Enrollment initially included uterine carcinosarcoma and was expanded to ovarian carcinosarcoma in June 2010 and then to include fallopian tube and peritoneal carcinosarcoma in October 2013. The primary analysis was restricted to patients with uterine carcinosarcoma.

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Preserved source evidence · Not medical advice