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Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC — OMET  

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
Randomized Phase II Trial Comparing Chemotherapy Combined With Stereotactic Radiotherapy and Stereotactic Radiotherapy Alone, for Treatment of Oligometastases in Squamous Cell Cancers of the Upper Aerodigestive Tract

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03070366
Study type Interventional
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 21, 2015
Completion date July 2026
View Details
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