Clinical trial NCT03401840: STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Head and neck cancers
Radiation oncology
Stereotactic radiotherapy
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: GORTEC
First posted: 2018-01-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: severe late toxicity
timeFrame: from 3 months to 2 years following the end of radiotherapy
Secondary outcomes:
measure: Local control
timeFrame: 2 years following the end of radiotherapy
measure: Locoregional control
timeFrame: 2 years following the end of radiotherapy
measure: Acute toxicity
timeFrame: from the first fraction to 3 months after the end of radiotherapy
measure: disease free survival (DFS)
timeFrame: 2 years following the end of radiotherapy
measure: Overall survival (OS)
timeFrame: 2 years following the end of radiotherapy
measure: Quality of life (global evaluation)
timeFrame: at baseline, 1 month, 1 year and 2 years post radiotherapy
measure: Quality of life (specific evaluation for Head and Neck Cancer)
timeFrame: at baseline, 1 month, 1 year and 2 years post radiotherapy
measure: Nutritional impact
timeFrame: during 2 years following the end of radiotherapy
measure: Nutritional support
timeFrame: during 2 years following the end of radiotherapy
measure: Predictive factors of toxicity
timeFrame: 2 years following the end of radiotherapy
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique bordeaux Nord Aquitaine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud /Site du Scorff
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier, Val d'Aurelle
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière - Charles Foix
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Grégoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire
city: Saint Priest en Jarez cedex
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'ouest, Site René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Jean Perrin
name: Julian BIAU
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.