Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer
1 other identifier
interventional
200
1 country
1
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 and late side effects without compromising tumor control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 head-and-neck-cancer
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedMarch 18, 2013
March 1, 2013
4.7 years
March 11, 2013
March 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
overall rate of late dysphagia and neck fibrosis
5 years
Secondary Outcomes (3)
locoregional control
5 years
Quality of life
5 years
Acute dysphagia
2 years
Study Arms (2)
control arm
ACTIVE COMPARATORNID2Gy = 50 Gy Swallowing apparatus: standard dose
Experimental de escalated arm
EXPERIMENTALNID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- University Hospital, Ghentcollaborator
Study Sites (1)
University Hospitals UZLeuven
Leuven, 3000, Belgium
Related Publications (1)
Deschuymer S, Nevens D, Duprez F, Daisne JF, Dok R, Laenen A, Voordeckers M, De Neve W, Nuyts S. Randomized clinical trial on reduction of radiotherapy dose to the elective neck in head and neck squamous cell carcinoma; update of the long-term tumor outcome. Radiother Oncol. 2020 Feb;143:24-29. doi: 10.1016/j.radonc.2020.01.005. Epub 2020 Feb 7.
PMID: 32044165DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 18, 2013
Study Start
May 1, 2008
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
March 18, 2013
Record last verified: 2013-03