STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins.

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Radiation: postoperative hypofractionated stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx pT1 or pT2 ((UICC 7th edition 2009) Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria : positive R1 margin (re-resection not proposed) close margin < 5 mm (re-resection not proposed) Margin estimated at risk, with uncertain pathological margin (re-resection not proposed) N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection) Age ≥ 18 years ECOG status ≤ 2 Written signed informed consent before any specific procedure of the protocol Affiliation to a social security scheme or beneficiary of such a scheme Exclusion Criteria: Other histology than squamous cell carcinoma pT3 or pT4 pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board Lymphovascular invasion justifying neck irradiation Neck irradiation decided in multidisciplinary tumor board Lack of at least one of the following elements : pre-operative medical imaging (CT scan or MRI) endoscopy report surgery report pathological report Prior radiotherapy to the head and neck area Distant metastasis Pregnant or nursing (lactating) woman women or men of childbearing age not taking adequate contraceptive measure participation in another investigational study within 4 weeks prior to inclusion History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postoperative SBRT<br>SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days | Radiation: postoperative hypofractionated stereotactic radiotherapy<br>* total dose of 36Gy in 6 fractions over 11-13 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe late toxicity | 2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification. | from 3 months to 2 years following the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | 2-year local control rate - Any local recurrence (T) will be considered as an event. | 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 | 2 years following the end of radiotherapy | 
| Acute toxicity | ≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification. | 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. | 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 | 2 years following the end of radiotherapy | 
| Quality of life (global evaluation) | evaluated by EORTC QLQC30 | 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 | at baseline, 1 month, 1 year and 2 years post radiotherapy | 
| Nutritional impact | evaluated by weight loss | during 2 years following the end of radiotherapy | 
| Nutritional support | evaluated by the use of feeding tubes | 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). | 2 years following the end of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancers, Radiation oncology, Stereotactic radiotherapy