Trials / Completed
CompletedNCT01287390
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2014-05-01
- Completion
- 2015-05-01
- First posted
- 2011-02-01
- Last updated
- 2016-01-27
Locations
2 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01287390. Inclusion in this directory is not an endorsement.