Head and Neck Neoplasms
Conditions
Keywords
Head and neck cancers, Radiation oncology, Stereotactic radiotherapy
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.
Interventions
total dose of 36Gy in 6 fractions over 11-13 days
Sponsors
GORTEC
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severe late toxicity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control | 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 |
| Acute toxicity | 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. |
| disease free survival (DFS) | 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. |
| Overall survival (OS) | 2 years following the end of radiotherapy | 2-year OS rate - OS is defined as time from randomization to death from any cause |
| Local control | 2 years following the end of radiotherapy | 2-year local control rate - Any local recurrence (T) will be considered as an event. |
| Quality of life (specific evaluation for Head and Neck Cancer) | at baseline, 1 month, 1 year and 2 years post radiotherapy | evaluated by EORTC QLQ HN35 module |
| Nutritional impact | during 2 years following the end of radiotherapy | evaluated by weight loss |
| Nutritional support | during 2 years following the end of radiotherapy | evaluated by the use of feeding tubes |
| Predictive factors of toxicity | 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). |
| Quality of life (global evaluation) | at baseline, 1 month, 1 year and 2 years post radiotherapy | evaluated by EORTC QLQC30 |
Countries
France
Outcome results
None listed