Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx, Primary Non-operated Squamous Cell Carcinoma of Hypopharynx, Primary Non-operated Squamous Cell Carcinoma of Larynx

Intervention / Treatment
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* Procedure: video fluoroscopy
* Procedure: extra imaging
* Other: scoring acute toxicity
* Other: scoring of late toxicity
* Other: scoring quality of life (QOL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard radiotherapy treatment<br>These patients receive the normal standard treatment. | Procedure: video fluoroscopy<br>* video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up<br>Other: scoring acute toxicity<br>* Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.<br>Other: scoring of late toxicity<br>* Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.<br>Other: scoring quality of life (QOL)<br>* Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).<br>|
| Experimental: adaptive radiotherapy<br>These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer. | Procedure: video fluoroscopy<br>* video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up<br>Procedure: extra imaging<br>* For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.<br>Other: scoring acute toxicity<br>* Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.<br>Other: scoring of late toxicity<br>* Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.<br>Other: scoring quality of life (QOL)<br>* Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of acute and late treatment-induced dysphagia | Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment. | after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute treatment-induced toxicity |  | weekly during treatment | 
| late treatment-induced toxicity |  | after 1, 3, 6, 9 and 12 months | 
| tumor response: imaging |  | after 3 months | 
| tumor response: clinical examination |  | after 1, 3, 6, 9 and 12 months | 
| local, regional and distant control: imaging |  | after 3 months | 
| local, regional and distant control: clinical examination |  | after 1,3, 6, 9 and 12 months | 
| local, regional and distant control: biopsy |  | from 3 months on | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx