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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00426-37 | Registry Identifier | ANSM |
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The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard radiotherapy | No Intervention | single pre-treatment planning before radiotherapy | |
| adaptative radiotherapy | Experimental | adaptive Radiotherapy based on a weekly replanning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adaptative radiotherapy | Radiation | weekly replanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary flow measure | The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy. | 12 months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Xerostomia | salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy | From before treatment to 24 months after the end of radiotherapy |
| Salivary flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud De Crevoisier, MD | Centre Eugène Marquis - Rennes - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Albi | France | ||||
| Clinique Pasteur - Saint Esprit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37261806 | Derived | Castelli J, Thariat J, Benezery K, Hasbini A, Gery B, Berger A, Liem X, Guihard S, Chapet S, Thureau S, Auberdiac P, Pommier P, Ruffier A, Perrier L, Devillers A, Campillo-Gimenez B, de Crevoisier R. Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Aug 1;9(8):1056-1064. doi: 10.1001/jamaoncol.2023.1352. |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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measured by scintigraphy |
| Before treatment and 12 months after the end of radiotherapy |
| Local control | analysed according stages T and N, HPV status | 2 years |
| Early and late toxicities | early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy | From beginning of the radiotherapy up to 2 years after the end of radiotherapy |
| Survival | overall and disease free survival | 2 years |
| Head and Neck functionality | MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy | Before treatment to 24 months after the end of radiotherapy |
| Brest |
| 29200 |
| France |
| CRLCC Baclesse | Caen | 14076 | France |
| CRLCC Oscar Lambret | Lille | 59020 | France |
| Centre Léon Bérard | Lyon | France |
| CRLCC Antoine Lacassagne | Nice | 06189 | France |
| CHU de la Milétrie | Poitiers | 86000 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| CRLCC Henri Becquerel | Rouen | France |
| Centre Paul Strauss | Strasbourg | France |
| CHU Tours | Tours | 37044 | France |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |