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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC-K16-164 | Other Grant/Funding Number | Directorate of Health Care Supply (DGOS), National Cancer Institute (INCa), France |
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| Name | Class |
|---|---|
| GORTEC | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postoperative SBRT | Experimental | SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| postoperative hypofractionated stereotactic radiotherapy | Radiation | total dose of 36Gy in 6 fractions over 11-13 days |
|
| 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 |
| 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 |
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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 :
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 :
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
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| Name | Affiliation | Role |
|---|---|---|
| Julian BIAU | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte Catherine | Avignon | France | ||||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41632122 | Derived | Biau J, Sun X, Liem X, Faivre JC, Eker E, Blanchard P, Tao Y, Dore M, Maingon P, Vulquin N, Alfonsi M, Thureau S, Huguet F, Racadot S, Thivat E, Molnar I, Boisselier P, Guihard S, Gallocher O, Dupin C, Batard S, Bourhis J, Lapeyre M. Postoperative SBRT and Severe Late Toxic Effects in Early-Stage Oropharyngeal and Oral Cavity Cancers: The STEREOPOSTOP-GORTEC 2017-03 Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2549975. doi: 10.1001/jamanetworkopen.2025.49975. | |
| 32758188 |
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| 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 |
| 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 |
| Hôpital Tenon | Paris | France |
| Hôpital Universitaire Pitié Salpêtrière - Charles Foix | Paris | France |
| Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux | Pessac | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | France |
| Institut Jean Godinot | Reims | France |
| Centre Henri Becquerel | Rouen | France |
| Centre Hospitalier Privé Saint Grégoire | Saint-Grégoire | France |
| Institut de Cancérologie de l'ouest, Site René Gauducheau | Saint-Herblain | France |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | France |
| Centre Paul Strauss | Strasbourg | France |
| Clinique Pasteur | Toulouse | France |
| Institut Claudius Regaud | Toulouse | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | France |
| Institut Gustave Roussy | Villejuif | France |
| Derived |
| Biau J, Thivat E, Millardet C, Saroul N, Pham-Dang N, Molnar I, Pereira B, Durando X, Bourhis J, Lapeyre M. 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: the STEREO POSTOP GORTEC 2017-03 trial. BMC Cancer. 2020 Aug 5;20(1):730. doi: 10.1186/s12885-020-07231-3. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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