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Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma


Phase 3
70 Years
N/A
Open (Enrolling)
Both
Head and Neck Squamous Cell Carcinoma

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Trial Information

Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Locoregional control

Outcome Description:

Patient alive with locoregional control at 6 months after the end of radiotherapy

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

GORTEC ELAN-RT

NCT ID:

NCT01864850

Start Date:

June 2013

Completion Date:

January 2018

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Elderly
  • Geriatry
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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