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De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Study acronym: DIREKHT2
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Identification, Study Status, Oversightv6
  2. Study Identification, Study Status, Oversightv5
  3. Start date changed from estimate of Feb 2024 to Jan 26, 2024v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2024 to Feb 2024
    • Site details revised
    v3
  5. Start date: Oct 2023 to Jan 2024
    • Primary completion date: Sep 2031 to Dec 2031
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.
Trial Details
NCT Number NCT06030440
Lead Sponsor University of Erlangen-Nürnberg Medical School
Conditions
(from sponsor)		 Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Oropharynx
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 508 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov