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This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy (75 Gy) plus cisplatin versus conventional radiotherapy (70 Gy) plus cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. The main end points are the rate of locoregional control and the rate of xerostomia at 2 years.
The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will receive concomitant cisplatin (100 mg/m² D1, D21, D42).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Conventional RT 70Gy + concomitant cisplatin |
|
| 2 | Experimental | IMRT 75Gy + concomitant cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT 75 Gy | Procedure | 50 Gy in PTV1 and 25 Gy in 10 fractions in PTV2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Loco regional control | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 2 years | |
| Xerostomia at 2 years (evaluated by parotid gland scintigraphy) | 2 years | |
| Quality of life (EORTC-QLQ-H&N35) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Bourhis, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Michel Lapeyre, MD | Centre Alexis Vautrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France | |||
| Institut Gustave Roussy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32417348 | Derived | Tao Y, Auperin A, Blanchard P, Alfonsi M, Sun XS, Rives M, Pointreau Y, Castelli J, Graff P, Wong Hee Kam S, Thariat J, Veresezan O, Heymann S, Renard-Oldrini S, Lafond C, Cornely A, Casiraghi O, Boisselier P, Lapeyre M, Biau J, Bourhis J. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial. Radiother Oncol. 2020 Sep;150:18-25. doi: 10.1016/j.radonc.2020.05.021. Epub 2020 May 15. |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| Conventional radiotherapy 70 Gy |
| Procedure |
50 Gy in PTV1 and 20 Gy in PTV2 |
|
| concomitant cisplatin | Drug | 100 mg/m2 D1, D22, D43 |
|
| 2 years |
| Villejuif |
| 94800 |
| France |
| D009057 |
| Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |