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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:
The total duration of the study for each patient will be 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helical intensity-modulated radiotherapy (IMRT) | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O) | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30949592 | Background | Esteyrie V, Gleyzolle B, Lusque A, Graff P, Modesto A, Rives M, Lapeyre M, Desrousseaux J, Graulieres E, Hangard G, Arnaud FX, Ferrand R, Delord JP, Poublanc M, Mounier M, Filleron T, Laprie A. The GIRAFE phase II trial on MVCT-based "volumes of the day" and "dose of the day" addresses when and how to implement adaptive radiotherapy for locally advanced head and neck cancer. Clin Transl Radiat Oncol. 2019 Mar 9;16:34-39. doi: 10.1016/j.ctro.2019.02.006. eCollection 2019 May. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 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 |