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

Centre Jean Perrin

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Radiation: postoperative hypofractionated stereotactic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03401840

PHRC-K16-164 (Other Grant/Funding Number)

2017-A02058-45

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

postoperative SBRT

Experimental group

Description:

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

Treatment:

Radiation: postoperative hypofractionated stereotactic radiotherapy