A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
GETUG-StORM-01
1 other identifier
interventional
77
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
Longer than P75 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
January 13, 2026
January 1, 2026
6.8 years
March 2, 2020
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
6 months post-randomization
Secondary Outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Until 1 month after end of treatment
Local control rate
3, 6 and 12 months after randomization
Overall control rate
3, 6 and 12 months after randomization
Study Arms (1)
Steretactic radiotherapy plus systemic treatment
EXPERIMENTALInterventions
Steretactic radiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- National Cancer Institute, Francecollaborator
- GETUGcollaborator
Study Sites (30)
Clinique Claude Bernard
Albi, France
Institut de Cancérologie de l'Ouest
Angers, France
Institut Bergonié
Bordeaux, France
Radiothérapie Bordeaux Nord Aquitaine
Bordeaux, France
Centre François Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, France
CHU Henri Mondor
Créteil, France
Centre Georges François LECLERC
Dijon, France
Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
Dijon, France
CHD Vendée
La Roche-sur-Yon, France
Centre de radiothérapie Guillaume le Conquérant
Le Havre, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
CHU La Timone
Marseille, France
Institut Paoli Calmette
Marseille, France
CHR
Metz, France
ICM
Montpellier, France
Institut de Cancérologie de Lorraine
Nancy, France
Institut de Cancérologie de l'Ouest
Nantes, France
Centre Antoine Lacassagne
Nice, France
Centre Haute Energie
Nice, France
Institut Curie
Paris, France
Groupement de radiothérapie Oncologie des Pyrénées
Pau, France
Centre Hospitalier Annecy Genevois
Pringy, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Etienne, France
Polyclinique de l'Ormeau
Tarbes, France
IUCT
Toulouse, France
Centre marie Curie
Valence, France
Institut Gustave Roussy
Villejuif, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 9, 2020
Study Start
July 1, 2020
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
August 1, 2029
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share