Participant flow

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix · Source last updated 2018-10-17

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

groups

1. description

   Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

   id

   FG000

   title

   Arm I (Paclitaxel, Cisplatin)

2. description

   Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV

   id

   FG001

   title

   Arm II (Vinorelbine, Cisplatin)

3. description

   Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies

   id

   FG002

   title

   Arm III (Gemcitabine, Cisplatin)

4. description

   Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV

   id

   FG003

   title

   Arm IV (Topotecan, Cisplatin)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Improper prior treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Poor risk

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         4

      type

      Pathology

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      No surgery

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      No tumor

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         117

      3. group Id

         FG002

         num Subjects

         119

      4. group Id

         FG003

         num Subjects

         118

      type

      STARTED

   2. achievements

      1. comment

         Evaluable (treatment)

         group Id

         FG000

         num Subjects

         103

      2. comment

         Evaluable (treatment)

         group Id

         FG001

         num Subjects

         108

      3. comment

         Evaluable (treatment)

         group Id

         FG002

         num Subjects

         112

      4. comment

         Evaluable (treatment)

         group Id

         FG003

         num Subjects

         111

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.

recruitment Details

From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.

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Preserved source evidence · Not medical advice