An interventional study of postoperative hypofractionated stereotactic radiotherapy in Head and Neck Neoplasms, sponsored by Centre Jean Perrin. Completed at 24 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Treatment
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.
Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :
Exclusion Criteria:
Lack of at least one of the following elements :
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Radiation: postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days
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
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
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Centre Jean Perrin