Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
NCT ID: NCT01287390
Last Updated: 2016-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-10-31
2015-05-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard radiotherapy treatment
These patients receive the normal standard treatment.
video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
scoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
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).
adaptive radiotherapy
These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
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.
scoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
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).
Interventions
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video fluoroscopy
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
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.
scoring acute toxicity
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
scoring of late toxicity
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
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).
Eligibility Criteria
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Inclusion Criteria
* Primary non-resected tumor and/or patients refused surgery
* Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
* Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
* Karnofsky performance status \>= 70 %
* Age \>= 18 years old
* Informed consent obtained, signed and dated before specific protocol procedures
Exclusion Criteria
* Prior irradiation to the head and neck region
* Surgery of the primary tumor except lymph node dissection prior to radiotherapy
* induction chemotherapy
* history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
* Distant metastases
* Creatinine clearance (Cockroft-Gault) =\< 60 milliliter/minute before treatment or creatinine value \> 1,3 milligram/deciliter
* Known allergy to the CT-contrast agents
* Pregnant or lactating women
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Wilfried De Neve, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2011/012
Identifier Type: -
Identifier Source: org_study_id
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