Participant flow

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor · Source last updated 2024-02-08

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

groups

1. description

   Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).

   id

   FG000

   title

   Average-Risk Group

2. description

   Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.

   id

   FG001

   title

   High-Risk Group

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Still on therapy

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Bone involvement confirmed by bone scan

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         5

      type

      Excessive toxicity

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Non-specified

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         11

      type

      Progressive disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         269

      2. group Id

         FG001

         num Subjects

         144

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         251

      2. group Id

         FG001

         num Subjects

         120

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         24

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 416 participants enrolled, three were ineligible and taken off study.

recruitment Details

416 participants were enrolled between 9/9/2003 and 3/7/2013.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice