Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC (ELAN-RT)

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Completed; Phase 3

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Radiation: Hypofractionated RT; Radiation: Standard RT

Study type: Interventional

Funder types: Other

Identifiers

NCT01864850

GORTEC ELAN-RT

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

202 participants in 2 patient groups

Standard RT

Active Comparator group

Description:

70 Gy / 7 weeks / 2 Gy per fraction

Treatment:

Radiation: Standard RT

Hypofractionated RT

Experimental group

Description:

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

Treatment:

Radiation: Hypofractionated RT