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

Primary Purpose

Head and Neck Neoplasms

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
postoperative hypofractionated stereotactic radiotherapy
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and neck cancers, Radiation oncology, Stereotactic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Sainte Catherine
  • Institut Bergonié
  • Polyclinique bordeaux Nord Aquitaine
  • Centre Jean Perrin
  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • Centre Hospitalier de Bretagne Sud /Site du Scorff
  • Centre Léon Bérard
  • Hôpital Nord Franche-Comté
  • Institut de Cancérologie de Montpellier, Val d'Aurelle
  • Hôpital Tenon
  • Hôpital Universitaire Pitié Salpêtrière - Charles Foix
  • Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
  • Centre Hospitalier Lyon-Sud
  • Institut Jean Godinot
  • Centre Henri Becquerel
  • Centre Hospitalier Privé Saint Grégoire
  • Institut de Cancérologie Lucien Neuwirth
  • Institut de Cancérologie de l'ouest, Site René Gauducheau
  • Centre Paul Strauss
  • Clinique Pasteur
  • Institut Claudius Regaud
  • Institut de Cancérologie de Lorraine
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

postoperative SBRT

Arm Description

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

Outcomes

Primary Outcome Measures

severe late toxicity
2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.

Secondary Outcome Measures

Local control
2-year local control rate - Any local recurrence (T) will be considered as an event.
Locoregional control
2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event
Acute toxicity
≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
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.
Overall survival (OS)
2-year OS rate - OS is defined as time from randomization to death from any cause
Quality of life (global evaluation)
evaluated by EORTC QLQC30
Quality of life (specific evaluation for Head and Neck Cancer)
evaluated by EORTC QLQ HN35 module
Nutritional impact
evaluated by weight loss
Nutritional support
evaluated by the use of feeding tubes
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).

Full Information

First Posted
December 19, 2017
Last Updated
March 6, 2023
Sponsor
Centre Jean Perrin
Collaborators
GORTEC
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1. Study Identification

Unique Protocol Identification Number
NCT03401840
Brief Title
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
Acronym
STEREOPOSTOP
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
Collaborators
GORTEC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Head and neck cancers, Radiation oncology, Stereotactic radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
postoperative SBRT
Arm Type
Experimental
Arm Description
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Intervention Type
Radiation
Intervention Name(s)
postoperative hypofractionated stereotactic radiotherapy
Intervention Description
total dose of 36Gy in 6 fractions over 11-13 days
Primary Outcome Measure Information:
Title
severe late toxicity
Description
2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Time Frame
from 3 months to 2 years following the end of radiotherapy
Secondary Outcome Measure Information:
Title
Local control
Description
2-year local control rate - Any local recurrence (T) will be considered as an event.
Time Frame
2 years following the end of radiotherapy
Title
Locoregional control
Description
2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event
Time Frame
2 years following the end of radiotherapy
Title
Acute toxicity
Description
≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.
Time Frame
from the first fraction to 3 months after the end of radiotherapy
Title
disease free survival (DFS)
Description
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.
Time Frame
2 years following the end of radiotherapy
Title
Overall survival (OS)
Description
2-year OS rate - OS is defined as time from randomization to death from any cause
Time Frame
2 years following the end of radiotherapy
Title
Quality of life (global evaluation)
Description
evaluated by EORTC QLQC30
Time Frame
at baseline, 1 month, 1 year and 2 years post radiotherapy
Title
Quality of life (specific evaluation for Head and Neck Cancer)
Description
evaluated by EORTC QLQ HN35 module
Time Frame
at baseline, 1 month, 1 year and 2 years post radiotherapy
Title
Nutritional impact
Description
evaluated by weight loss
Time Frame
during 2 years following the end of radiotherapy
Title
Nutritional support
Description
evaluated by the use of feeding tubes
Time Frame
during 2 years following the end of radiotherapy
Title
Predictive factors of toxicity
Description
clinical and/or dosimetric factors associated to late severe toxicities (grade ≥ 3 related to SBRT according to CTCAE V4.03 classification).
Time Frame
2 years following the end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian BIAU
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Polyclinique bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud /Site du Scorff
City
Lorient
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
Facility Name
Institut de Cancérologie de Montpellier, Val d'Aurelle
City
Montpellier
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
Hôpital Universitaire Pitié Salpêtrière - Charles Foix
City
Paris
Country
France
Facility Name
Hôpital Haut-Lévêque - Groupe hospitalier sud - CHU de Bordeaux
City
Pessac
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Centre Hospitalier Privé Saint Grégoire
City
Saint Grégoire
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint Priest en Jarez cedex
Country
France
Facility Name
Institut de Cancérologie de l'ouest, Site René Gauducheau
City
Saint-Herblain
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32758188
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.
Results Reference
derived

Learn more about this trial

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

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