Informations générales (source: ClinicalTrials.gov)
A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Interventional
Phase 2
Centre Francois Baclesse (Voir sur ClinicalTrials)
juillet 2020
août 2029
02 février 2026
Every year, 12500 primary renal cell carcinoma (RCC) are diagnosed in France. Metastases
occur in half of RCC patients.
Management of metastatic RCC is based on systemic treatments (targeted
therapies/immunotherapy). However, resistance to systemic treatment is frequent. In case
of progression, usual therapeutic attitude is initiating another systemic therapy.
Because of the emergence of resistant tumor clonal cells, some patients progress only on
few sites while the rest of tumor burden is controlled. In this setting named
oligoprogressive disease [isolated progression of <3-5 metastase(s)], ablative treatments
of these evolving metastatic sites could allow a disease control and a reduced risk of
new metastases occurrence by tumor-cell reembolization. Such strategy is challenging to
prolong ongoing systemic treatment and delay further lines.
Although RCC was considered radioresistant and radiotherapy with conventional
fractionation was mainly used for palliation of symptoms, stereotactic radiotherapy
(SRT), by delivering high dose in one or few fractions, allows local control for about
90% of RCC metastases through various radiobiological pathways. Furthermore, some data
suggest that high-dose focal irradiation of RCC could induce a systemic antitumor
response mediated by immunologic effectors(1). This phenomenon ("abscopal effect") could
be enhanced in patients under immunotherapy, including anti-PD1.
Several retrospective studies and one non-randomized phase-II study highly suggest the
interest of SRT as focal ablative treatment in RCC oligometastases with excellent local
control rates and low toxicity(2,3).
Furthermore, the multicentric retrospective study the sponsor recently conducted within
the GETUG group among 101 metastatic RCC patients with oligoprogression under systemic
therapy highlighted that SRT on progressive sites provided a median of 8.6-month
progression-free survival and allowed to continue current systemic line for 10.5 months.
However, to date, there are no prospective data assessing the interest of SRT for
management of oligoprogressive metastatic RCC.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:12 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLINIQUE CLAUDE BERNARD | Laurent VOTRON, MD | Contact (sur clinicalTrials) | |||
| INSTITUT GUSTAVE ROUSSY | Mario TERLIZZI, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de radiothérapie Guillaume le Conquérant - Le Havre 3003796 - France | Romain MALLET, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Annecy Genevois - Pringy 2985305 - France | CARBONNAUX Mélodie, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand 3024635 - France | Jessica MIROIR, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon 2996944 - France | Laurence BAWWENS, MD | Contact (sur clinicalTrials) | |||
| Centre marie Curie - Valence 2971053 - France | Jean-Baptiste GUY, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers 3037656 - France | Jérémy COLLIAUX, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Nantes 2990969 - France | Stephane SUPIOT, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice 2990440 - France | Delphine BORCHIELLINI, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen 3029241 - France | Nazim KHALLADI, MD | Contact (sur clinicalTrials) | |||
| Centre Georges François LECLERC - Dijon 3021372 - France | Magali QUIVRIN, MD | Contact (sur clinicalTrials) | |||
| Centre Haute Energie - Nice 2990440 - France | Audrey CLAREN-MERCATI, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen 2982652 - France | Maximilien ROGE, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille 2998324 - France | David PASQUIER, MD | Contact (sur clinicalTrials) | |||
| CHD Vendée - La Roche-sur-Yon 3006767 - France | Emmanuelle REYGANE-VEYRA, MD | Contact (sur clinicalTrials) | |||
| CHR - Metz 2994160 - France | Xavier MICHEL, MD | Contact (sur clinicalTrials) | |||
| CHU Henri Mondor - Créteil 3022530 - France | Yacid BELKACEMI, MD | Contact (sur clinicalTrials) | |||
| CHU La Timone - Marseille 2995469 - France | Xavier MURACCIOLE, MD | Contact (sur clinicalTrials) | |||
| Groupement de radiothérapie Oncologie des Pyrénées - Pau 2988358 - France | GILLIOT Olivier, MD | Contact (sur clinicalTrials) | |||
| ICM - Montpellier 2992166 - France | David AZRIA, PhD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux 3031582 - France | Paul SARGOS, MD | Contact (sur clinicalTrials) | |||
| Institut Curie - Paris 2988507 - France | CREHANGE Gilles, Pr | Contact (sur clinicalTrials) | |||
| Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône) - Dijon 3021372 - France | Alexis LEPINOY, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de la Loire Lucien Neuwirth - Saint-Etienne 2980291 - France | Nicolas MAGNE, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Nancy 2990999 - France | Anais STEFANI, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmette - Marseille 2995469 - France | Naji SALEM, MD | Contact (sur clinicalTrials) | |||
| IUCT - Toulouse 2972315 - France | Jonathan KHALIFA, MD | Contact (sur clinicalTrials) | |||
| Polyclinique de l'Ormeau - Tarbes 2973385 - France | Guillaume PEYRAGA, MD | Contact (sur clinicalTrials) | |||
| Radiothérapie Bordeaux Nord Aquitaine - Bordeaux 3031582 - France | Sigolène GALLAND-GIRODET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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
Exclusion Criteria:
- 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