Status:
COMPLETED
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03
Lead Sponsor:
Centre Jean Perrin
Collaborating Sponsors:
GORTEC
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03401840
Start Date
January 23 2018
End Date
September 28 2023
Last Update
February 13 2025
Active Locations (24)
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1
Institut Sainte Catherine
Avignon, France
2
Institut Bergonié
Bordeaux, France
3
Polyclinique bordeaux Nord Aquitaine
Bordeaux, France
4
Centre Jean Perrin
Clermont-Ferrand, France