Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy

Study Overview
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Brief Summary
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This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer. Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT. For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment. 3 recontouring modalities will be evaluated for the study: Manuel recontouring (standard method) Precise ART™ deformed contours Precise RTX™ deformed contours The total duration of the study for each patient will be 7 weeks.

Official Title
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Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Helical intensity-modulated radiotherapy (IMRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands) Cancer with nodal involvement (at least T3 or involved node >2 cm) Eastern Cooperative Oncology Group performance status 0 or 1 No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy) Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting Patient affiliated to the french social security system. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure. Exclusion Criteria: Patient with metastatic cancer Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities) Patient with recurrent disease Patient who required urgent surgical treatment Contraindications to radiotherapy History of cancer within 5 years Patient already included in another therapeutic trial Pregnant or breastfeeding women Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures Patient protected by law

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radiotherapy treatment<br> | Other: Helical intensity-modulated radiotherapy (IMRT)<br>* Helical intensity-modulated radiotherapy (35 fractions, 5 fractions per week) will be administered during 7 weeks: 2 Gy per fraction on tumor and 1.6 Gy per fraction on bilateral lymph node areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with Dice Similarity Coefficient (DSC) of the volumes of left and right parotid gland superior to 0.85 (DSC > 0.85) |  | 7 weeks for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with DSC > 0.85 for other organs at risk (oral cavity, medullar canal, mandible,brain stem, larynx) |  | 7 weeks for each patient | 
| Rate of patients with DSC > 0.85 for target volumes (clinical target volume, gross target volume, planning target volume) |  | 7 weeks for each patient | 
| Time saving defined by the difference between standard recontouring time (manuel recontouring) and experimental recontouring time (Precise ART™ or Precise RTX™) |  | 7 weeks for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adaptive radiotherapy