Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
NCT ID: NCT01341535
Last Updated: 2022-12-14
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
2011-09-30
2021-07-15
Brief Summary
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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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adaptive DPBN
This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment.
Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.
Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
standard IMRT
This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers.
Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.
standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.
Interventions
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Adaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
standard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.
Eligibility Criteria
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Inclusion Criteria
* Primary unresectable tumor and/or patients that refused surgery
* Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy
* Karnofsky performance status \>= 70 %
* Age \>= 18 years old
* Informed consent obtained, signed and dated before specific protocol procedures
Exclusion Criteria
* Treatment combined with brachytherapy
* Prior irradiation to the head and neck region
* 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 for at least 5 years.
* Distant metastases
* Pregnant or lactating women
* Creatinine clearance (Cockcroft-Gault) =\< 60 mL/min
* 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, Ph.D., M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Department of Radiotherapy, University Hospital Ghent
Ghent, , Belgium
Clinique & Materinité Sainte Elisabeth
Namur, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2010/567
Identifier Type: -
Identifier Source: org_study_id
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