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

March 6, 2023 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • 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 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
        • Hopital Nord Franche-Comte
      • 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 Cancérologie 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

Centre Jean Perrin

Collaborators

GORTEC

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)

January 23, 2018

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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