STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03 (STEREOPOSTOP)

February 11, 2025 updated by: Centre Jean Perrin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Avignon, France
        • Institut Sainte Catherine
      • Bordeaux, France
        • Institut Bergonié
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Dijon, France
        • Centre Georges François Leclerc
      • Lille, France
        • Centre Oscar Lambret
      • Lorient, France
        • Centre Hospitalier de Bretagne Sud /Site du Scorff
      • Lyon, France
        • Centre Leon Berard
      • Montbéliard, France
        • Hôpital Nord Franche-Comté
      • Montpellier, France
        • Institut de Cancérologie de Montpellier, Val d'Aurelle
      • Paris, France
        • Hôpital Tenon
      • Paris, France
        • Hôpital Universitaire Pitié Salpêtrière - Charles Foix
      • Pessac, France
        • Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon-Sud
      • Reims, France
        • Institut Jean Godinot
      • Rouen, France
        • Centre Henri Becquerel
      • Saint Grégoire, France
        • Centre Hospitalier Privé Saint Grégoire
      • Saint Priest en Jarez cedex, France
        • Institut de Cancérologie Lucien Neuwirth
      • Saint-Herblain, France
        • Institut de Cancérologie de l'ouest, Site René Gauducheau
      • Strasbourg, France
        • Centre Paul Strauss
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • Clinique Pasteur
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancerologie de Lorraine
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Radiation: postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from 3 months to 2 years following the end of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 2 years following the end of radiotherapy
2-year local control rate - Any local recurrence (T) will be considered as an event.
2 years following the end of radiotherapy
Locoregional control
Time Frame: 2 years following the end of radiotherapy
2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event
2 years following the end of radiotherapy
Acute toxicity
Time Frame: from the first fraction to 3 months after the end of radiotherapy
≤ 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)
Time Frame: 2 years following the end of radiotherapy
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)
Time Frame: 2 years following the end of radiotherapy
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)
Time Frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
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)
Time Frame: at baseline, 1 month, 1 year and 2 years post radiotherapy
evaluated by EORTC QLQ HN35 module
at baseline, 1 month, 1 year and 2 years post radiotherapy
Nutritional impact
Time Frame: during 2 years following the end of radiotherapy
evaluated by weight loss
during 2 years following the end of radiotherapy
Nutritional support
Time Frame: during 2 years following the end of radiotherapy
evaluated by the use of feeding tubes
during 2 years following the end of radiotherapy
Predictive factors of toxicity
Time Frame: 2 years following the end of radiotherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Jean Perrin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GORTEC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julian BIAU, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A02058-45
  • PHRC-K16-164 (Other Grant/Funding Number: Directorate of Health Care Supply (DGOS), National Cancer Institute (INCa), France)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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