Head and Neck Cancer
Conditions
Keywords
Adaptive radiotherapy
Brief summary
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.
Interventions
OTHERHelical intensity-modulated radiotherapy (IMRT)
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.
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands) 3. Cancer with nodal involvement (at least T3 or involved node \>2 cm) 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy) 6. Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting 7. Patient affiliated to the french social security system. 8. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure.
Exclusion criteria
1. Patient with metastatic cancer 2. Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities) 3. Patient with recurrent disease 4. Patient who required urgent surgical treatment 5. Contraindications to radiotherapy 6. History of cancer within 5 years 7. Patient already included in another therapeutic trial 8. Pregnant or breastfeeding women 9. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures 10. Patient protected by law
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed