Head and Neck NeoplasmsSTEREOPOSTOPNCT03401840
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
A study testing postoperative hypofractionated stereotactic radiotherapy in people with Head and Neck Neoplasms, run by Centre Jean Perrin at 24 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- postoperative hypofractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 24 sitesFrance
- Study dates
- 23 Jan 2018to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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 :
Show all 17Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Institut Sainte Catherine
Avignon
Institut Bergonié
Bordeaux
Polyclinique bordeaux Nord Aquitaine
Bordeaux
Centre Jean Perrin
Clermont-Ferrand
Centre Georges François Leclerc
Dijon
Centre Oscar Lambret
Lille
Centre Hospitalier de Bretagne Sud /Site du Scorff
Lorient
Centre Léon Bérard
Lyon
Hôpital Nord Franche-Comté
Montbéliard
Institut de Cancérologie de Montpellier, Val d'Aurelle
Montpellier
Hôpital Tenon
Paris
Hôpital Universitaire Pitié Salpêtrière - Charles Foix
Paris
Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
Pessac
Centre Hospitalier Lyon-Sud
Pierre-Bénite
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire
Institut de Cancérologie de l'ouest, Site René Gauducheau
Saint-Herblain
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Centre Paul Strauss
Strasbourg
Clinique Pasteur
Toulouse
Institut Claudius Regaud
Toulouse
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Institut Gustave Roussy
Villejuif
About this study
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.
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- postoperative hypofractionated stereotactic radiotherapy
- Keywords
- Head and neck cancers, Radiation oncology, Stereotactic radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative hypofractionated stereotactic radiotherapyRadiation
total dose of 36Gy in 6 fractions over 11-13 days
| Study group | Role | What they receive |
|---|---|---|
| postoperative SBRT | Experimental | SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days Receives: Radiation: postoperative hypofractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe late toxicity
2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Measured: from 3 months to 2 years following the end of radiotherapy
Secondary outcomes (10)
Local control
2-year local control rate - Any local recurrence (T) will be considered as an event.
Measured: 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
Measured: 2 years following the end of radiotherapy
Acute toxicity
≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Measured: 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.
Measured: 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
Measured: 2 years following the end of radiotherapy
Quality of life (global evaluation)
evaluated by EORTC QLQC30
Measured: 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
Measured: at baseline, 1 month, 1 year and 2 years post radiotherapy
Nutritional impact
evaluated by weight loss
Measured: during 2 years following the end of radiotherapy
Nutritional support
evaluated by the use of feeding tubes
Measured: 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).
Measured: 2 years following the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start23 Jan 2018
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- GORTEC
- Responsible party
- Sponsor
- Investigators
- Julian BIAU, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401840
- Sponsor's protocol ID
- 2017-A02058-45
- Other IDs
- PHRC-K16-164
- Acronym
- STEREOPOSTOP
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2017
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41632122Biau 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.
PubMed 32758188
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03401840
- Acronym / sponsor ID
- STEREOPOSTOP / 2017-A02058-45
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and neck cancers, Radiation oncology, Stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- GORTEC
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative SBRT | Experimental | Radiation: postoperative hypofractionated stereotactic radiotherapySBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative hypofractionated stereotactic radiotherapytotal dose of 36Gy in 6 fractions over 11-13 days | Radiation | postoperative SBRT |
Primary outcome
severe late toxicity
Time frame: 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.
10 secondary outcomes
Local control
Time frame: 2 years following the end of radiotherapy
Locoregional control
Time frame: 2 years following the end of radiotherapy
Acute toxicity
Time frame: from the first fraction to 3 months after the end of radiotherapy
disease free survival (DFS)
Time frame: 2 years following the end of radiotherapy
Overall survival (OS)
Time frame: 2 years following the end of radiotherapy
Quality of life (global evaluation)
Time frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
Quality of life (specific evaluation for Head and Neck Cancer)
Time frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
Nutritional impact
Time frame: during 2 years following the end of radiotherapy
Nutritional support
Time frame: during 2 years following the end of radiotherapy
Predictive factors of toxicity
Time frame: 2 years following the end of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 41632122Biau 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.
- Derived from this study: PubMed 32758188Biau 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.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian BIAU principal investigator
Centre Jean Perrin
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative hypofractionated stereotactic radiotherapy in people with Head and Neck Neoplasms, run by Centre Jean Perrin at 24 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe late toxicity (time frame: from 3 months to 2 years following the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.