Etude : GETUG STORM-01 /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : GETUG STORM-01

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Radiothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 20/12/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude randomisée de phase II évaluant la radiothérapie stéréotaxique comme stratégie thérapeutique du carcinome rénal avec métastases oligoprogressives

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The sponsor aim to prospectively evaluate the interest of SRT as a therapeutic strategy for local control of oligoprogressive metastatic RCC under ongoing systemic treatment, and consequently delay subsequent systemic treatment.

2 arms:
- Experimental: Steretactic radiotherapy plus systemic treatment
- Active Comparator: Systemic treatment

Phase : II

Stade : Métastatique

1, 2
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 : - Clear cell renal cancer histologically proved (association with other histologic component are permitted)
- Patients of good or intermediate prognostic, according to Heng criteria
- Extracerebral metastatic disease documented with imagery
- Patients treated in first or second line systemic therapy
- Systemic treatment may be targeted therapies (tyrosine kinase inhibitors or mammalian target of rapamycin inhibitors) and/or immunotherapy according to French applicable standards; patients treated in a clinical trial are also eligible if allowed by trial sponsor
- Oligoprogressive disease documented with imagery, defined as the emergence or progression of 1 to 3 metastases and progression localized in up to 2 organs
- Oligoprogressive disease confirmed with 2 CT scans performed 2 months apart
- At least one measurable progressing metastasis according to R.E.C.I.S.T. criteria v1.1
- All oligoprogressive target lesions measuring ≤ 4 cm
- Good general condition (WHO performance status ≤ 2)
- All progressive lesions have to be accessible to SRT, performed concurrently or sequentially
- No contraindication to systemic therapy and stereotactic radiation therapy
- Patients aged 18 years or older
- Signed informed consent form
- Patients affiliated to the social security system

Critères de non-inclusion : - -More than 3 progressive metastases
- Non measurable disease according R.E.C.I.S.T. criteria
- Patients who received 3 or more lines of systemic therapy
- Inability to treat all progressive metastatic sites with SRT
- Previous radiation therapy performed in ≥ 1 target lesion
- At least 1 oligoprogressive target lesion measuring > 4 cm
- Presence of brain metastases
- Presence of ultra-central pulmonary metastasis
- Progressing metastasis in a long bone
- At least 1 progressive metastasis requiring surgical treatment
- Current or past history of second neoplasm diagnosed within the last 5 years
- Pregnancy or breast feeding or inadequate contraceptive measures
- Patients who cannot be adequately followed up
- Patient deprived of freedom or under guardianship
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04299646
Promoteur :
Centre François BACLESSE
Type de sponsor : Institutionnel
14000 CAEN

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Emmanuel MEYER

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Statut de l'essai : OUVERT

MAJ : 17/07/2020