Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01812486

Enrollment

200

Registered

2013-03-18

Start date

2008-05-31

Completion date

2013-03-31

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

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 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

Interventions

RADIATIONdose de escalation

RADIATIONstandard dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
overall rate of late dysphagia and neck fibrosis	5 years

Secondary

Measure	Time frame
locoregional control	5 years
Quality of life	5 years
Acute dysphagia	2 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026