Participant flow

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer · Source last updated 2026-01-06

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

groups

1. description

   Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

   id

   FG000

   title

   IMRT

2. description

   Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.

   id

   FG001

   title

   IMRT Plus Cetuximab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         23

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         314

      2. group Id

         FG001

         num Subjects

         313

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         287

      2. group Id

         FG001

         num Subjects

         290

      type

      Eligible

   3. achievements

      1. group Id

         FG000

         num Subjects

         282

      2. group Id

         FG001

         num Subjects

         276

      comment

      Adverse event population

      type

      Eligible and Started Protocol Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         287

      2. group Id

         FG001

         num Subjects

         290

      comment

      Participants contributing data to results are considered to have completed the study.

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

After trial registration, tissue slides from the tumor specimen were sent to the NRG Oncology biorepository for immunohistochemical analysis of epidermal growth factor receptor (EGFR) expression and (for oropharynx cancer) p16, a surrogate biomarker for human papillomavirus (HPV) positivity. From 702 registered participants, 627 were randomized.

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

Preserved source evidence · Not medical advice