Dose De-escalation to the Elective Nodal Sites, the Swallowing Apparatus and Neck Soft Tissues for Head and Neck Cancer: Multi-centre, Randomized Phase III Trial Using Image-guided Intensity-modulated Radiotherapy (IG-IMRT)
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Dose De-escalation to the Elective Nodal Sites, the Swallowing Apparatus and Neck Soft Tissues for Head and Neck Cancer: Multi-centre, Randomized Phase III Trial Using Image-guided Intensity-modulated Radiotherapy (IG-IMRT)
1. Study hypothesis
Dose de-escalation in the elective nodal sites and off-target regions of the swallowing
apparatus delivered by IMRT does reduce overall rate of late dysphagia and neck
fibrosis comparing to the standard dose to the elective nodal sites.
2. Primary endpoint
To estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year
after the end of radiotherapy in patients receiving dose de-escalation to the elective
nodal sites and off-target regions of the swallowing apparatus applying IMRT.
3. Secondary endpoints
Local, regional and distant control Recurrence and site of recurrence Overall, disease-free
and disease-specific survival Acute toxicity Quality of life
Inclusion Criteria:
oral cavity, oropharynx, hypopharynx and larynx SCC Histolocervical lymph node metastases
of unknown primary cancer Primary unresectable tumor and/or patients refused surgery Stage
T2-4; T3-4 N0 Tany N1-3 for laryngeal cancer Karnofsky performance status ≥70% Age ≥ 18
years old
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 at least 5 years Distant metastases Pregnant or lactating women
Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to
return for follow-up visits, and unlikely to complete the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall rate of late dysphagia and neck fibrosis
Outcome Time Frame:
5 years
Safety Issue:
No
Authority:
Belgium: Federal Agency for Drugs and Medicinal Devices
Study ID:
S50809
NCT ID:
NCT01812486
Start Date:
May 2008
Completion Date:
March 2013
Related Keywords:
- Head and Neck Cancer
- Head and Neck Neoplasms
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