STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
- Conditions
- Head and Neck Neoplasms
- Interventions
- Radiation: postoperative hypofractionated stereotactic radiotherapy
- Registration Number
- NCT03401840
- Lead Sponsor
- Centre Jean Perrin
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description postoperative SBRT postoperative hypofractionated stereotactic radiotherapy SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
- Primary Outcome Measures
Name Time Method severe late toxicity from 3 months to 2 years following the end of radiotherapy 2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 2 years following the end of radiotherapy 2-year OS rate - OS is defined as time from randomization to death from any cause
Local control 2 years following the end of radiotherapy 2-year local control rate - Any local recurrence (T) will be considered as an event.
Locoregional control 2 years following the end of radiotherapy 2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event
Quality of life (global evaluation) at baseline, 1 month, 1 year and 2 years post radiotherapy evaluated by EORTC QLQC30
Acute toxicity from the first fraction to 3 months after the end of radiotherapy ≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
disease free survival (DFS) 2 years following the end of radiotherapy 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.
Quality of life (specific evaluation for Head and Neck Cancer) at baseline, 1 month, 1 year and 2 years post radiotherapy evaluated by EORTC QLQ HN35 module
Nutritional impact during 2 years following the end of radiotherapy evaluated by weight loss
Nutritional support during 2 years following the end of radiotherapy evaluated by the use of feeding tubes
Predictive factors of toxicity 2 years following the end of radiotherapy clinical and/or dosimetric factors associated to late severe toxicities (grade ≥ 3 related to SBRT according to CTCAE V4.03 classification).
Trial Locations
- Locations (24)
Hôpital Tenon
🇫🇷Paris, France
Polyclinique bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonié
🇫🇷Bordeaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Hospitalier de Bretagne Sud /Site du Scorff
🇫🇷Lorient, France
Hôpital Nord Franche-Comté
🇫🇷Montbéliard, France
Institut de Cancérologie de Montpellier, Val d'Aurelle
🇫🇷Montpellier, France
Centre Léon Bérard
🇫🇷Lyon, France
Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
🇫🇷Pessac, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Bénite, France
Hôpital Universitaire Pitié Salpêtrière - Charles Foix
🇫🇷Paris, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint Priest en Jarez cedex, France
Centre Hospitalier Privé Saint Grégoire
🇫🇷Saint Grégoire, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut de Cancérologie de l'ouest, Site René Gauducheau
🇫🇷Saint-Herblain, France
Clinique Pasteur
🇫🇷Toulouse, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France