The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
total dose of 36Gy in 6 fractions over 11-13 days
Institut Sainte Catherine
Avignon, France
severe late toxicity
2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Time frame: from 3 months to 2 years following the end of radiotherapy
Local control
2-year local control rate - Any local recurrence (T) will be considered as an event.
Time frame: 2 years following the end of radiotherapy
Locoregional control
2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event
Time frame: 2 years following the end of radiotherapy
Acute toxicity
≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Time frame: from the first fraction to 3 months after the end of radiotherapy
disease free survival (DFS)
2-year DFS rate - DFS is time from randomization to the date of first occurrence of any locoregional recurrence, distant progression or death from any cause.
Time frame: 2 years following the end of radiotherapy
Overall survival (OS)
2-year OS rate - OS is defined as time from randomization to death from any cause
Time frame: 2 years following the end of radiotherapy
Quality of life (global evaluation)
evaluated by EORTC QLQC30
Time frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
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Institut Bergonié
Bordeaux, France
Polyclinique bordeaux Nord Aquitaine
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Hospitalier de Bretagne Sud /Site du Scorff
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital Nord Franche-Comté
Montbéliard, France
Institut de Cancérologie de Montpellier, Val d'Aurelle
Montpellier, France
...and 14 more locations
Quality of life (specific evaluation for Head and Neck Cancer)
evaluated by EORTC QLQ HN35 module
Time frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
Nutritional impact
evaluated by weight loss
Time frame: during 2 years following the end of radiotherapy
Nutritional support
evaluated by the use of feeding tubes
Time frame: during 2 years following the end of radiotherapy
Predictive factors of toxicity
clinical and/or dosimetric factors associated to late severe toxicities (grade ≥ 3 related to SBRT according to CTCAE V4.03 classification).
Time frame: 2 years following the end of radiotherapy