STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
NCT ID: NCT03401840
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2018-01-23
2023-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days
Interventions
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postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GORTEC
OTHER
Centre Jean Perrin
OTHER
Responsible Party
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Principal Investigators
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Julian BIAU
Role: PRINCIPAL_INVESTIGATOR
Centre Jean Perrin
Locations
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Institut Sainte Catherine
Avignon, , France
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
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
Countries
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References
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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.
Other Identifiers
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PHRC-K16-164
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017-A02058-45
Identifier Type: -
Identifier Source: org_study_id
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