Participant flow

Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) · Source last updated 2023-09-11

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

groups

1. description

   radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

   id

   FG000

   title

   RT Alone

2. description

   Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

   id

   FG001

   title

   RT & Concurrent CT

3. description

   Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

   id

   FG002

   title

   RT + Adjuvant CT

4. description

   Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

   id

   FG003

   title

   RT & Concurrent CT + Adjuvant CT

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         49

      4. group Id

         FG003

         num Subjects

         40

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         28

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         11

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         8

      4. group Id

         FG003

         num Subjects

         16

      type

      Various different reasons/missing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         188

      3. group Id

         FG002

         num Subjects

         186

      4. group Id

         FG003

         num Subjects

         188

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         175

      2. group Id

         FG001

         num Subjects

         163

      3. group Id

         FG002

         num Subjects

         109

      4. group Id

         FG003

         num Subjects

         93

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         25

      3. group Id

         FG002

         num Subjects

         77

      4. group Id

         FG003

         num Subjects

         95

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The patients were first registered to the trial by authorized sites. For all patients, tumor and blood samples had to be sent for histology review, 1p/19q analysis and O6-Methylguanine-DNA Methyltransferase (MGMT) assay. If inclusion was based on central pathology and 1p/19q diagnosis the patient could be randomized into the trial once found eligible at central assessment.

recruitment Details

After registration step was completed, eligible patients were randomized into the trial within 8 days from the start of radiotherapy; at this time, all baseline requirements for the study had to be fulfilled.

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

Preserved source evidence · Not medical advice