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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017047-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-fraction radiotherapy with concomitant 5FU and Hydrea | Active Comparator | six 5-day cycles with a 9-day rest period between each cycle (split course). Each cycle includes : a single-fraction at a dose of 2 Gy per session for 5 sessions, combined with 5FU (800 mg/m2/day) and Hydrea (500 mg x 3/day) over the 5 days of the cycle. The total dose of radiotherapy is therefore 60 Gy delivered over 11 weeks. |
|
| hyperfractionated radiotherapy with concomitant Cetuximab | Experimental | Bifractionated radiotherapy at a dose of 1.2 Gy per session at a rate of 2 sessions per day, at least 6h apart, 5 days per week over 5 weeks, without a split course, combined with Cetuximab. The total dose of radiotherapy is 60 Gy delivered over 5 weeks. Cetuximab (ErbituxÃ’) is to be administered in a 2-hour IV infusion at a dose of 400 mg/m2, 8 days before the start of radiotherapy, then in a 1-hour infusion at a dose of 250 mg/m2 on days 1, 8, 15, 22 and 29 of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-fraction radiotherapy with concomitant 5FU and Hydrea | Radiation | single-fraction radiotherapy with concomitant 5FU and Hydrea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity requiring an interruption of radiotherapy for more than 2 weeks | 6 months | |
| Overall survival at 3 years and loco-regional control at 3 years | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | 94800 | France |
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| Label | URL |
|---|---|
| ORL clinical trials on line in Institut Gustave Roussy | View source |
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| hyperfractionated radiotherapy with concomitant Cetuximab | Radiation | hyperfractionated radiotherapy with concomitant Cetuximab |
|
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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