Etude : ZOSTER /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ZOSTER

Nom :

Traitement : Métastatique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 30/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.
Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

Experimental: RSHF + zoledronic acid
Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).

Active Comparator: RSHF
Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.

Phase : III

Stade : Métastasique

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
Age ≥ 18 years old ;
Life expectancy greater than 1 year;
OMS or PS ≤ 2 ;
Effective contraception for women of childbearing age;
Patient information and free, informed and written consent, signed by the patient and investigator;
Patient affiliated or beneficiary of the social security system.

Critères de non-inclusion : Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment;
Patient who has received external irradiation from the proposed irradiation area > 20 Gy ;
Signs of neurological compression;
Spinal cord compression or epidural damage requiring surgery before radiotherapy;
Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient;
History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery;
Previous (less than 2 years) or ongoing treatment with a bisphosphonate;
Creatinine clearance < 30 ml/min;
Pregnant or breastfeeding woman;
Patient protected or under guardianship or incapable of giving consent;
Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03951493
Promoteur :
INSTITUT DE CANCEROLOGIE DE L'OUEST
Type de sponsor : Institutionnel
INSTITUT DE CANCEROLOGIE DE L'OUEST
44000 NANTES

Coordonnateur :
KAREN CLEMENT-COLMOU,
Karen.Clement-Colmou@ico.unicancer.fr
0240679325
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Sébastien THUREAU

TEC / ARC / IDE :
Clotilde PUPIN
clothilde.pupin@
chb.unicancer.fr
02.76.67.30.50

Statut de l'essai : OUVERT

MAJ : 30/01/2020