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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— ELAN-RT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864850
• Other study ID #: GORTEC ELAN-RT
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2013
• Est. completion date: June 5, 2020

Study information

• Verified date: September 2023
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 5, 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• Standard RT
70 Gy / 7 weeks / 2 Gy per fraction
• 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

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou	Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control	Patient alive with locoregional control at 6 months after the end of radiotherapy	6 months
Secondary	Acute toxicity	Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade	3 months
Secondary	Late toxicity	Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade	18 months
Secondary	Autonomy	Autonomy according to ADL scale	18 months
Secondary	Health related quality of life	Quality of life according to EORTC QLQ-C30 and QLQ-HN35	18 months
Secondary	Overall survival	Overall survival	18 months
Secondary	Locoregional progression	Locoregional progression	18 months
Secondary	metastasis progression	metastasis progression	18 months
Secondary	Progression free survival	Progression free survival	18 months

External Links

•   GORTEC