Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC
Conditions
Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
HNSCC, Elderly, Geriatry
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Standard RT Type: Radiation
Name: Hypofractionated RT Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
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
Locations
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Yungan TAO, MD, PhD - yungan.tao@igr.fr
Centre Hospitalier Princesse Grace
Monaco, Monaco
Status: Not yet recruiting
Contact: Cecile ORTHOLAN, MD - cecile.ortholan@chpg.mc
Start Date
June 2013
Completion Date
January 2018
Sponsors
Groupe Oncologie Radiotherapie Tete et Cou
Source
Groupe Oncologie Radiotherapie Tete et Cou
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page