Participant flow

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20

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

groups

1. description

   Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

   id

   FG000

   title

   IMRT + Cisplatin

2. description

   Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

   id

   FG001

   title

   IMRT + Cetuximab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         23

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      HIV positive

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         424

      2. group Id

         FG001

         num Subjects

         425

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         406

      2. group Id

         FG001

         num Subjects

         399

      comment

      All eligible participants

      type

      Eligible

   3. achievements

      1. group Id

         FG000

         num Subjects

         398

      2. group Id

         FG001

         num Subjects

         394

      comment

      Eligible and started study treatment

      type

      Started treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         369

      2. group Id

         FG001

         num Subjects

         363

      comment

      Eligible, started study treatment, and had adverse events (AE) assessment 1 month post-treatment

      type

      AE assessed 1 month post-treatment (PT)

   5. achievements

      1. group Id

         FG000

         num Subjects

         359

      2. group Id

         FG001

         num Subjects

         367

      comment

      Eligible, started study treatment, and had adverse events assessment 3 months post-treatment

      type

      AE assessed 3 months PT

   6. achievements

      1. group Id

         FG000

         num Subjects

         361

      2. group Id

         FG001

         num Subjects

         352

      comment

      Eligible, started study treatment, and had adverse events assessment 6 months post-treatment

      type

      AE assessed 6 months PT

   7. achievements

      1. group Id

         FG000

         num Subjects

         360

      2. group Id

         FG001

         num Subjects

         351

      comment

      Eligible, started study treatment, and had adverse events assessment 1 year post-treatment

      type

      AE assessment 1 year PT

   8. achievements

      1. group Id

         FG000

         num Subjects

         311

      2. group Id

         FG001

         num Subjects

         303

      comment

      Eligible, started study treatment, and had adverse events assessment 2 years post-treatment

      type

      AE assessed 2 years PT

   9. achievements

      1. group Id

         FG000

         num Subjects

         92

      2. group Id

         FG001

         num Subjects

         86

      comment

      Eligible, started study treatment, and had adverse events assessment 5 years post-treatment

      type

      AE assessed 5 years PT

   10. achievements

       1. group Id

          FG000

          num Subjects

          267

       2. group Id

          FG001

          num Subjects

          267

       comment

       Eligible, started study treatment, and had dental health assessment 1 year post-treatment

       type

       Dental health assessed 1 year PT

   11. achievements

       1. group Id

          FG000

          num Subjects

          208

       2. group Id

          FG001

          num Subjects

          201

       comment

       Eligible, started study treatment, and had dental health assessment 2 years post-treatment

       type

       Dental health assessed 2 years PT

   12. achievements

       1. group Id

          FG000

          num Subjects

          44

       2. group Id

          FG001

          num Subjects

          43

       comment

       Eligible, started study treatment, and had dental health assessment 5 years post-treatment

       type

       Dental health assessed 5 years PT

   Show more (12 of 16)

   title

   Overall Study

pre Assignment Details

Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized.

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Preserved source evidence · Not medical advice