Informations générales (source: ClinicalTrials.gov)
A Randomized Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases (GETUG-StORM-01)
Interventional
Phase 2
Centre Francois Baclesse (Voir sur ClinicalTrials)
juillet 2020
janvier 2026
13 août 2024
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 | 04/12/2024 12:44:17 | 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 François Baclesse - 14076 - Caen - France | Nazim KHALLADI, MD | Contact (sur clinicalTrials) | |||
| Centre Haute Energie - Nice - France | Charles-Henry CANOVA, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Jessica MIROIR, MD | Contact (sur clinicalTrials) | |||
| Centre marie Curie - Valence - France | Jean-Baptiste GUY, MD | Contact (sur clinicalTrials) | |||
| CHU La Timone - Marseille - France | Xavier MURACCIOLE, MD | Contact (sur clinicalTrials) | |||
| Clinique Claude Bernard - Albi - France | Laurent VOTRON, MD | Contact (sur clinicalTrials) | |||
| ICM - Montpellier - France | David AZRIA, PhD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Paul SARGOS, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de la Loire Lucien Neuwirth - Saint-Étienne - France | Nicolas MAGNE, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Nancy - France | Anais STEFANI, MD | Contact (sur clinicalTrials) | |||
| IUCT - Toulouse - France | Jonathan KHALIFA, MD | Contact (sur clinicalTrials) | |||
| Radiothérapie Bordeaux Nord Aquitaine - Bordeaux - France | Sigolène GALLAND-GIRODET, 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 de radiothérapie Guillaume le Conquérant - Le Havre - France | Romain MALLET, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Salvatore COZZI, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille - France | David PASQUIER, MD | Contact (sur clinicalTrials) | |||
| CHR - Metz - France | Xavier MICHEL, MD | Contact (sur clinicalTrials) | |||
| CHU - Nîmes - France | Marie-Pierre FARCY JACQUET, MD | Contact (sur clinicalTrials) | |||
| CHU - Rouen - France | Laetitia AUGUSTO, MD | Contact (sur clinicalTrials) | |||
| CHU Henri Mondor - Créteil - France | Yacid BELKACEMI, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône) - Dijon - France | Alexis LEPINOY, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Angers - France | Jérémy COLLIAUX, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Nantes - France | Stephane SUPIOT, MD | Contact (sur clinicalTrials) | |||
| Institut Gustave Roussy - Villejuif - France | Mario TERLIZZI, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmette - Marseille - France | Naji SALEM, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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