Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbo, 5FU, Cetuximab | Experimental | 6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbo, 5FU, Cetuximab | Drug | 6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w) Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response and acute toxicity | Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy | 1 month after the end of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Best objective tumor response | Best objective tumor response during treatment | 6 weeks after the end of treatment |
| Overall survival | Overall survival |
Not provided
Inclusion Criteria:
The disease:
General:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Dracénie | Draguignan | 83300 | France | |||
| Institut Gustave Roussy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38759667 | Derived | Guigay J, Le Caer H, Ferrand FR, Geoffrois L, Saada-Bouzid E, Fayette J, Sire C, Cupissol D, Blot E, Guillet P, Pavillet J, Bozec L, Capitain O, Rolland F, Debourdeau P, Pointreau Y, Falandry C, Lopez S, Coutte A, Chatellier T, Dalloz P, Ortholan C, Michel C, Lacas B, Cheurfa N, Schwob D, Bourhis J, Mertens C, Auperin A; ELAN Group including Gustave Roussy, Unicancer GERICO and H&N groups, and GORTEC. Adapted EXTREME regimen in the first-line treatment of fit, older patients with recurrent or metastatic head and neck squamous cell carcinoma (ELAN-FIT): a multicentre, single-arm, phase 2 trial. Lancet Healthy Longev. 2024 Jun;5(6):e392-e405. doi: 10.1016/S2666-7568(24)00048-5. Epub 2024 May 14. |
| Label | URL |
|---|---|
| GORTEC | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year after the end of treatment |
| progression free survival | progression free survival | 1 year after the end of treatment |
| Duration of response under cetuximab maintenance therapy | Duration of response under cetuximab maintenance therapy | 1 year after the end of maintenance |
| Toxicity of cetuximab maintenance therapy | Toxicity of cetuximab maintenance therapy | 3 months after the end of maintenance |
| autonomy | Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment | 1 month after the end of treatment |
| Health related quality of life | Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires | 1 month after the end of chemotherapy |
| Villejuif |
| 94805 |
| France |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided