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Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck

NCT01287390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-01-27

No results posted yet for this study

Summary

Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:

* adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
* reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.

Conditions

  • Primary Non-operated Squamous Cell Carcinoma of Oral Cavity
  • Primary Non-operated Squamous Cell Carcinoma of Oropharynx
  • Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
  • Primary Non-operated Squamous Cell Carcinoma of Larynx

Interventions

PROCEDURE

video fluoroscopy

video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up

PROCEDURE

extra imaging

For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.

OTHER

scoring acute toxicity

Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.

OTHER

scoring of late toxicity

Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.

OTHER

scoring quality of life (QOL)

Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H\&N 35).

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wilfried De Neve, PhD, MD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2015-05-31

Countries

  • Belgium

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 NCT01287390 on ClinicalTrials.gov