NCT03401840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

5.7 years

First QC Date

December 19, 2017

Last Update Submit

February 11, 2025

Conditions

Head and Neck Neoplasms

Keywords

Head and neck cancersRadiation oncologyStereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Local control

    2 years following the end of radiotherapy

  • Locoregional control

    2 years following the end of radiotherapy

  • Acute toxicity

    from the first fraction to 3 months after the end of radiotherapy

  • disease free survival (DFS)

    2 years following the end of radiotherapy

  • Overall survival (OS)

    2 years following the end of radiotherapy

  • +5 more secondary outcomes

Study Arms (1)

postoperative SBRT

EXPERIMENTAL

SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days

Radiation: postoperative hypofractionated stereotactic radiotherapy

Interventions

postoperative hypofractionated stereotactic radiotherapyRADIATION

total dose of 36Gy in 6 fractions over 11-13 days

postoperative SBRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Institut Sainte Catherine

Avignon, France

Location

Institut Bergonié

Bordeaux, France

Location

Polyclinique bordeaux Nord Aquitaine

Bordeaux, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Hospitalier de Bretagne Sud /Site du Scorff

Lorient, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

Institut de Cancérologie de Montpellier, Val d'Aurelle

Montpellier, France

Location

Hôpital Tenon

Paris, France

Location

Hôpital Universitaire Pitié Salpêtrière - Charles Foix

Paris, France

Location

Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux

Pessac, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Institut Jean Godinot

Reims, France

Location

Centre Henri Becquerel

Rouen, France

Location

Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, France

Location

Institut de Cancérologie de l'ouest, Site René Gauducheau

Saint-Herblain, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Clinique Pasteur

Toulouse, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (2)

  • 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.

    PMID: 41632122DERIVED

  • 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.

    PMID: 32758188DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Julian BIAU

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 17, 2018

Study Start

January 23, 2018

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(24)