Status:
COMPLETED
Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
University Hospital, Ghent
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a reduction of acute...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01812486
Start Date
May 1 2008
End Date
March 1 2013
Last Update
March 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals UZLeuven
Leuven, Belgium, 3000