Clinical trial · Interventional
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
- 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)
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by: * adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues; * reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Non-operated Squamous Cell Carcinoma of Hypopharynx | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Larynx | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Oral Cavity | — | UNRESOLVED | — |
| Primary Non-operated Squamous Cell Carcinoma of Oropharynx | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| extra imaging | Procedure | — | UNRESOLVED |
| scoring acute toxicity | Other | — | UNRESOLVED |
| scoring of late toxicity | Other | — | UNRESOLVED |
| scoring quality of life (QOL) | Other | — | UNRESOLVED |
| video fluoroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- standard radiotherapy treatment
- description
- These patients receive the normal standard treatment.
- interventionNames
- Procedure: video fluoroscopy
- Other: scoring acute toxicity
- Other: scoring of late toxicity
- Other: scoring quality of life (QOL)
- type
- EXPERIMENTAL
- label
- adaptive radiotherapy
- description
- These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer.
- interventionNames
- Procedure: video fluoroscopy
- Procedure: extra imaging
- Other: scoring acute toxicity
- Other: scoring of late toxicity
- Other: scoring quality of life (QOL)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx. * Primary non-resected tumor and/or patients refused surgery * Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3 * Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven * Karnofsky performance status \>= 70 % * Age \>= 18 years old * Informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * Treatment combined with brachytherapy * Prior irradiation to the head and neck region * Surgery of the primary tumor except lymph node dissection prior to radiotherapy * induction chemotherapy * 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 * Creatinine clearance (Cockroft-Gault) =\< 60 milliliter/minute before treatment or creatinine value \> 1,3 milligram/deciliter * Known allergy to the CT-contrast agents * Pregnant or lactating women * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
References
Publications (0)
Data not yet available