Clinical trial · Interventional
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)
NCT01812486CI-TRIAL-00009744completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dose de escalation | Radiation | — | UNRESOLVED |
| standard dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- NID2Gy = 50 Gy Swallowing apparatus: standard dose
- interventionNames
- Radiation: standard dose
- type
- EXPERIMENTAL
- label
- Experimental de escalated arm
- description
- NID2Gy = 40 Gy Swallowing apparatus: Dmax ≤ 60 Gy at 1 cm Dmax ≤ 50 Gy at 1.5 cm from the GTV or PSTB edge
- interventionNames
- Radiation: dose de escalation
Primary outcomes (1)
- measure
- overall rate of late dysphagia and neck fibrosis
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDeschuymer 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 32044165