Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
HNSCC, Elderly, Geriatry
Brief summary
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.
Interventions
RADIATIONStandard RT
70 Gy / 7 weeks / 2 Gy per fraction
RADIATIONHypofractionated RT
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
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Groupe Oncologie Radiotherapie Tete et Cou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Radiotherapy
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 70 or over * SIOG group 2 (vulnerable) * Life expectancy \> 12 weeks * PS \< 2 * Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary). * First line treatment * At least one measurable lesion (RECIST) * Stage II to IV * Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized * Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area * Consent form signed
Exclusion criteria
* Primary squamous cell carcinoma of sinus, the skin or of the salivary glands * Stage I cancer * Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy * Prior radiotherapy of head and neck area * Concurrent chemotherapy or immunotherapy or hormonotherapy * Induction chemotherapy * Concomitant infection requiring IV antibiotics * cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted) * conditions that could lead to bad compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control | 6 months | Patient alive with locoregional control at 6 months after the end of radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicity | 18 months | Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade |
| Autonomy | 18 months | Autonomy according to ADL scale |
| Health related quality of life | 18 months | Quality of life according to EORTC QLQ-C30 and QLQ-HN35 |
| Acute toxicity | 3 months | Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade |
| Locoregional progression | 18 months | Locoregional progression |
| metastasis progression | 18 months | metastasis progression |
| Progression free survival | 18 months | Progression free survival |
| Overall survival | 18 months | Overall survival |
Countries
France, Monaco
Outcome results
None listed