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De-Intensification Radiotherapy Postoperative Head Neck

NCT02528955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-17

No results posted yet for this study

Summary

In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with \>= pT3 and or pN+ postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and or R1/2 resection.

Locoregional control rates are over 80% after surgery and radio(chemo)therapy. But many patients suffer from therapy-related long-term side-effects, like xerostomia, dysphagia, fibrosis, trismus etc.

The aim of this study is to investigate if depending on primary tumor stage, quality of resection ( resection margin) and number of lymph node metastasis and performed neck dissection an adapted de-intensified dose- and target volume concept may be performed without reducing locoregional-control but with reducing radiotherapy-related side-effects.

Conditions

  • Cancer of Head and Neck

Interventions

RADIATION

A: De-Intensification RT primary tumor region

A: * Reduction of radiation dose in the primary tumor region to 56 Gy, * Elective Radiotherapy of both neck sides

RADIATION

B: De-Intensification RT contralateral lymph nodes

B: * No dose reduction in primary tumor region (prescribed dose in primary tumor region: 64 Gy) * Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation

RADIATION

C. De-Intensification RT primary tumor region AND contralateral lymph nodes

C: * Reduction of radiation dose in the primary tumor region to 56 Gy, AND * Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Rainer Fietkau · Dept. of Radiooncology, University Hospital Erlangen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2022-10-31
Completion
2025-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528955 on ClinicalTrials.gov