Clinical trial NCT01864850: Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
Official title: Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: HNSCC
Elderly
Geriatry
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2013-05-30
Enrollment: 202
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Radiotherapy
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Locoregional control
timeFrame: 6 months
Secondary outcomes:
measure: Acute toxicity
timeFrame: 3 months
measure: Late toxicity
timeFrame: 18 months
measure: Autonomy
timeFrame: 18 months
measure: Health related quality of life
timeFrame: 18 months
measure: Overall survival
timeFrame: 18 months
measure: Locoregional progression
timeFrame: 18 months
measure: metastasis progression
timeFrame: 18 months
measure: Progression free survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References: