Brief Summary

This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life.

The current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine.

This randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord.

The primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment.

Eligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity.

The hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.

Conditions

• Epiduritis
• Vertebral Bone Metastasis

Intervention / Treatment

• Radiation: Stereotactic Body Radiotherapy (SBRT)
• Radiation: Conventional External Beam Radiotherapy

Primary Outcome Measures

• 1-year Clinical Disease Control Rate (12 months after randomization)
  Proportion of participants who are alive 12 months after randomization without clinical progression of the treated spinal lesion and without neurological deterioration attributable to the treated lesion during the 12-month follow-up.

Countries

France

Locations and Investigators

• Institut de Cancerologie de L'Ouest, Angers, France
  • Jeremy COLLIAUX, MD
• CLCC Ste Catherine - Institut du cancer Avignon/Provence, Avignon, France
  • Pierre TREMOLIERES, MD
• Chu de Brest, Brest, France
  • Francois LUCIA, MD
• CHD Vendée, La Roche-sur-Yon, France
  • Emmanuelle REYGAGNE-VIERA, MD
• Centre Gillaume le Conquérant, Le Havre, France
  • Paul LESUEUR, MD
• Clinique Victor Hugo, Le Mans, France
  • Yoann POINTREAU, MD
• Groupe Hospitalier Bretagne Sud (GHBS), Lorient, France
  • Guillaume BERA, MD
• Institut de Cancérologie Radiothérapie Bretillien (ICRB), Rennes, France
  • Francois RIET, MD
• Centre Henri Becquerel, Rouen, France
  • Sébastien THUREAU, MD
• Institut de Cancérologie de l'Ouest, Saint-Herblain, France
  • Martin LANGE, MD
  • Martin LANGE, MD (Principal Investigator)
• Clinique mutualiste de l'Estuaire, Saint-Nazaire, France
  • Vincent LIBOIS, MD
• Clinique de la Côte d'Emeraude, St-Malo, France
  • Nicolas JAKSIC, MD
• Chru Bretonneau, Tours, France
  • Astrid THOMIN, MD
• Clinique Saint Yves, Vannes, France
  • Osman EL KABBAJ, MD

Study Officials

• Loïg VAUGIER, MD (Principal Investigator) — Institut de Cancérologie de l'Ouest