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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy combined with stereotactic radiotherapy (RT) | Active Comparator | Chemotherapy is based on patient Performance Status (PS) and comorbidities:
Cycle 1 of systemic treatment will be administered before the start of the stereotactic RT. Then, following cycles will be performed after the end of stereotactic irradiation. Cetuximab maintenance: 250 mg/m² iv weekly. It will be given only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until progression or unacceptable toxicity. |
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| stereotactic radiotherapy | Experimental | Splitting will be based on the tumor diameter, and proximity of organs at risk which constitutes any limiting toxicities. It will be 3 or 5 fractions based on the recommendations (CARO-Stereotactic Body Radiation Therapy (SBRT) 2012) and for the purpose of harmonization practices. The prescription dose is 3 x 10 = 30 Gy 3 x 11 = 33 Gy or 3 x 15 = 45 Gy (if 3 fractions) with the possibility of 3 x 20 Gy to the peripheral lung nodules with tracking in Cyberknife or 5 x 7 = 35 Gy or 5 Gy x 10 = 50 (if 5 fractions). Beyond 3 cm of tumor diameter and / or to a distance of less than 1 cm from the GTV in an organ critical risk (eg spinal cord), a splitting up into 5 sessions must be privileged. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord Franche Comté | Montbéliard | 25209 | France |
The Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic radiotherapy | Radiation | Stereotactic radiotherapy |
|
Toxicity of grade > or equal to 3, occurring within the first 6 months of treatment |
| up to 6 months |
| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |