NCT03070366

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Chemotherapy	* cisplatin * 5FU * carboplatin * cetuximab
RADIATION	Stereotactic radiotherapy	Stereotactic radiotherapy

Timeline

• Start date: 2015-09-21
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2017-03-03
• Last updated: 2025-09-02

Locations

1 site across 1 country: France