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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03401840




Registration number
NCT03401840
Ethics application status
Date submitted
19/12/2017
Date registered
17/01/2018

Titles & IDs
Public title
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
Scientific 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.
Secondary ID [1] 0 0
PHRC-K16-164
Secondary ID [2] 0 0
2017-A02058-45
Universal Trial Number (UTN)
Trial acronym
STEREOPOSTOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - postoperative hypofractionated stereotactic radiotherapy

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


Treatment: Other: postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
severe late toxicity
Timepoint [1] 0 0
from 3 months to 2 years following the end of radiotherapy
Secondary outcome [1] 0 0
Local control
Timepoint [1] 0 0
2 years following the end of radiotherapy
Secondary outcome [2] 0 0
Locoregional control
Timepoint [2] 0 0
2 years following the end of radiotherapy
Secondary outcome [3] 0 0
Acute toxicity
Timepoint [3] 0 0
from the first fraction to 3 months after the end of radiotherapy
Secondary outcome [4] 0 0
disease free survival (DFS)
Timepoint [4] 0 0
2 years following the end of radiotherapy
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
2 years following the end of radiotherapy
Secondary outcome [6] 0 0
Quality of life (global evaluation)
Timepoint [6] 0 0
at baseline, 1 month, 1 year and 2 years post radiotherapy
Secondary outcome [7] 0 0
Quality of life (specific evaluation for Head and Neck Cancer)
Timepoint [7] 0 0
at baseline, 1 month, 1 year and 2 years post radiotherapy
Secondary outcome [8] 0 0
Nutritional impact
Timepoint [8] 0 0
during 2 years following the end of radiotherapy
Secondary outcome [9] 0 0
Nutritional support
Timepoint [9] 0 0
during 2 years following the end of radiotherapy
Secondary outcome [10] 0 0
Predictive factors of toxicity
Timepoint [10] 0 0
2 years following the end of radiotherapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Avignon
Country [2] 0 0
France
State/province [2] 0 0
Bordeaux
Country [3] 0 0
France
State/province [3] 0 0
Clermont-Ferrand
Country [4] 0 0
France
State/province [4] 0 0
Dijon
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Lorient
Country [7] 0 0
France
State/province [7] 0 0
Lyon
Country [8] 0 0
France
State/province [8] 0 0
Montbéliard
Country [9] 0 0
France
State/province [9] 0 0
Montpellier
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
France
State/province [11] 0 0
Pessac
Country [12] 0 0
France
State/province [12] 0 0
Pierre-Bénite
Country [13] 0 0
France
State/province [13] 0 0
Reims
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Saint Grégoire
Country [16] 0 0
France
State/province [16] 0 0
Saint Priest en Jarez cedex
Country [17] 0 0
France
State/province [17] 0 0
Saint-Herblain
Country [18] 0 0
France
State/province [18] 0 0
Strasbourg
Country [19] 0 0
France
State/province [19] 0 0
Toulouse
Country [20] 0 0
France
State/province [20] 0 0
Vandœuvre-lès-Nancy
Country [21] 0 0
France
State/province [21] 0 0
Villejuif

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Jean Perrin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GORTEC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julian BIAU
Address 0 0
Centre Jean Perrin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03401840