Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Oligometastasis, stereotactic irradiation
Brief summary
The aim of this study is to evaluate the rate of living patients at 1 year with a quality of life criteria (no decrease) and reduced toxicities. This criteria will be compared in both groups., A cost effectiveness study is scheduled also.
Detailed description
Patients with cancers of aerodigestive tract have metastases limited in their evolution and a pauci-metastatic disease. In these cases, systemic therapy is the standard attitude. However, patients often received chemotherapy in their history and response rates are relatively low. The median survival is between 7 and 11 months with secondary effects and degradation of quality of life. It is a palliative treatment. Data on systemic treatment in the context of a micro-metastatic disease are limited. In contrast, stereotactic irradiation in pauci-metastatic context leads to better local control rates and may sustainedly reduce the progression of metastatic disease. Stereotactic radiotherapy is increasing use in clinical practice for limited metastatic stages (oligo metastatic with 1-3 synchronized metastases). Radiotherapy in this indication has major advantages and a similar efficacy compared with other ablative treatments.
Interventions
DRUGChemotherapy
* cisplatin * 5FU * carboplatin * cetuximab
RADIATIONStereotactic radiotherapy
Stereotactic radiotherapy
Sponsors
Groupe Oncologie Radiotherapie Tete et Cou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * PS:0-2 * Estimated life expectancy ≥ 6 months * Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck * Target metastases can be treated in stereotactic radiotherapy * 1-3 synchronized metastases with unrestricted anatomic site * Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV) * Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm * Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV * Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion * In case of cerebral metastases, MRI diagnostic is required * If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible * If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline * In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician * No chemotherapy or local treatment of metastases in the previous 6 months * Laboratory tests consistent with the achievement of chemotherapy: Leukocytes\> 3,000 / mm3 (including polynuclear\> 2000 / mm3) platelets\> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin \<2.5 upper limit of normal (ULN) * Affiliation to an health insurance * Informed Consent Form signed
Exclusion criteria
* Concomitant participation in other interventional clinical trial within 4 weeks before inclusion * Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months * metachronous primitive tumor (second cancer) uncontrolled. * contraindication to any systemic therapy (chemotherapy and / or targeted therapy) * Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab * Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV) * Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix * Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship * Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival without quality of life deterioration | 1 year | Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1 year | — |
| Progression free survival | through study completion, an average of 1 year | — |
| Number of participants with adverse events grade 3 as assessed by CTCAE v4.0 within the first 6 months of treatment | up to 6 months | Toxicity of grade \> or equal to 3, occurring within the first 6 months of treatment |
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 1 year | — |
| Overall response rate | through study completion, an average of 1 year | — |
Countries
France
Outcome results
None listed