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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: Standard RT; Radiation: Hypofractionated RT

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Monaco
  • Monaco, Monaco, 98 000
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard RT; 70 Gy / 7 weeks / 2 Gy per fraction	Radiation: Standard RT; 70 Gy / 7 weeks / 2 Gy per fraction
Experimental: Hypofractionated 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	Radiation: Hypofractionated 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional control	Patient alive with locoregional control at 6 months after the end of radiotherapy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	18 months
Acute toxicity	Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade	3 months
Late toxicity	Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade	18 months
Autonomy	Autonomy according to ADL scale	18 months
Health related quality of life	Quality of life according to EORTC QLQ-C30 and QLQ-HN35	18 months
Locoregional progression	Locoregional progression	18 months
metastasis progression	metastasis progression	18 months
Progression free survival	Progression free survival	18 months

Collaborators and Investigators

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborators: Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

Helpful Links

• GORTEC

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2013
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimated): May 30, 2013

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; HNSCC; Geriatry
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: GORTEC ELAN-RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.