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
Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard RT | Active Comparator | 70 Gy / 7 weeks / 2 Gy per fraction |
|
| Hypofractionated RT | Experimental | 55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard RT | Radiation | 70 Gy / 7 weeks / 2 Gy per fraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control | Patient alive with locoregional control at 6 months after the end of radiotherapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade | 3 months |
| Late toxicity | Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | 94805 | France | |||
| Centre Hospitalier Princesse Grace |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41713468 | Derived | Ortholan C, Auperin A, Tao Y, Renard S, Pointreau Y, Lafond C, Bera G, Boisselier P, Benezery K, Racadot S, Huguet F, Bollet M, Braccini AL, Khoury C, Jacquot S, Villa J, Martin L, Di Rito A, Wiazzane N, Goineau A, Dupin C, Cartier L, Ruffier A, Cheurfa N, Schwob D, Mertens C, Le Caer H, Bourhis J, Guigay J, Sun XS; ELAN Group including Gustave Roussy, Unicancer GERICO and the H&N groups, and the GORTEC. Hypofractionated split-course versus standard radiotherapy in frail older patients with head and neck squamous-cell carcinoma (ELAN-RT trial): a non-inferiority, multicentre, open-label, randomised controlled trial. Lancet Healthy Longev. 2026 Jan;7(1):100812. doi: 10.1016/j.lanhl.2025.100812. Epub 2026 Feb 16. |
| Label | URL |
|---|---|
| GORTEC | View source |
Not provided
Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Radiotherapy
Not provided
Not provided
Not provided
Not provided
| Hypofractionated RT |
| Radiation |
55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy |
|
| 18 months |
| Autonomy | Autonomy according to ADL scale | 18 months |
| Health related quality of life | Quality of life according to EORTC QLQ-C30 and QLQ-HN35 | 18 months |
| Overall survival | Overall survival | 18 months |
| Locoregional progression | Locoregional progression | 18 months |
| metastasis progression | metastasis progression | 18 months |
| Progression free survival | Progression free survival | 18 months |
| Monaco |
| 98 000 |
| Monaco |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |