Participant flow

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors · Source last updated 2025-02-06

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

groups

1. description

   Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered

   id

   FG000

   title

   Arm I

2. description

   Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion

   id

   FG001

   title

   Arm II

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      treatment interruption

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         98

      2. group Id

         FG001

         num Subjects

         105

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         91

      2. group Id

         FG001

         num Subjects

         91

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 263 patients registered 255 were evaluated for biomarker decrease after one cycle of BEP. Eight patients were not evaluated for biomarker decrease: 6 patients died early, 1 patient 1 withdrew consent and 1 patient was included by error. 1 patient was not covered by EC approval and excluded froma analysis. The 203 patients with unfavorable decrease in tumor biomarkers were randomized in Arm I (98 patients) or Arm II (105 patients).

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Preserved source evidence · Not medical advice