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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
* cisplatin * 5FU * carboplatin * cetuximab
Stereotactic radiotherapy
Hôpital Nord Franche Comté
Montbéliard, France
Overall Survival without quality of life deterioration
Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment
Time frame: 1 year
Overall Survival
Time frame: 1 year
Progression free survival
Time frame: 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
Toxicity of grade \> or equal to 3, occurring within the first 6 months of treatment
Time frame: up to 6 months
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 year
Overall response rate
Time frame: through study completion, an average of 1 year
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