Standard RT
Radiation70 Gy / 7 weeks / 2 Gy per fraction
NCT Number: NCT01864850
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.
Looking for future studies?
Notify Me70 year and older
All sexes
Interventional
Phase 3
Institut Gustave Roussy, Villejuif, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
70 Gy / 7 weeks / 2 Gy per fraction
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
Time frame: 6 months
Patient alive with locoregional control at 6 months after the end of radiotherapy
Time frame: 3 months
Acute toxicity according to the CTC NCI V4 - rate of toxicity by type and by grade
Time frame: 18 months
Late toxicity according to the RTOG late toxicity scale - rate of toxicity by type and by grade
Time frame: 18 months
Autonomy according to ADL scale
Time frame: 18 months
Quality of life according to EORTC QLQ-C30 and QLQ-HN35
Time frame: 18 months
Overall survival
Time frame: 18 months
Locoregional progression
Time frame: 18 months
metastasis progression
Time frame: 18 months
Progression free survival
Groupe Oncologie Radiotherapie Tete et Cou
Other
Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma
Acronym: ELAN-RT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06307093
Carcinoma, Carcinoma, Squamous Cell
Istra, Moscow Oblast, Russia
View Trial DetailsNCT07435324
Carcinoma, Carcinoma, Squamous Cell
Arkhangelsk, Russia
View Trial DetailsNCT07435311
Carcinoma, Carcinoma, Squamous Cell
Barnaul, Russia
View Trial DetailsNCT07682285
Cancer-related Fatigue, Carcinoma
Taipei, Taiwan
View Trial Details