Metastatic Renal Cell CarcinomaPhase 2GETUG-StORM-01NCT04299646
A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
A Phase 2 study testing Steretactic radiotherapy in people with Metastatic Renal Cell Carcinoma and Radiotherapy, run by Centre Francois Baclesse at 30 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Radiotherapy
- What is being tested?
- Steretactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 30 sitesFrance
- Study dates
- 1 Jul 2020to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 30 recruiting
- Not yet recruiting
Clinique Claude Bernard
Albi
Laurent VOTRON, MD
Laurent VOTRON, MD
- Recruiting
Institut de Cancérologie de l'Ouest
Angers
Jérémy COLLIAUX, MD
Jérémy COLLIAUX, MD
- Not yet recruiting
Institut Bergonié
Bordeaux
Paul SARGOS, MD
Paul SARGOS, MD
- Not yet recruiting
Radiothérapie Bordeaux Nord Aquitaine
Bordeaux
Sigolène GALLAND-GIRODET, MD
Sigolène GALLAND-GIRODET, MD
- Recruiting
Centre François Baclesse
Caen, 14076
Nazim KHALLADI, MD, +33 2 31 45 50 50, n.khalladi@baclesse.unicancer.fr
Jean-Michel jm.grellard@baclesse.unicancer.fr, +33 2 31 45 50 02, jm.grellard@baclesse.unicancer.fr
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand
Jessica MIROIR, MD
Jessica MIROIR, MD
- Not yet recruiting
CHU Henri Mondor
Créteil
Yacid BELKACEMI, MD
Yacid BELKACEMI, MD
- Not yet recruiting
Centre Georges François LECLERC
Dijon
Magali QUIVRIN, MD, 33 380 73 75 18, MQuivrin@cgfl.fr
Magali QUIVRIN, MD
- Recruiting
Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
Dijon
Alexis LEPINOY, MD
Alexis LEPINOY, MD
- Not yet recruiting
CHD Vendée
La Roche-sur-Yon
Emmanuelle REYGANE-VEYRA, MD, 33 2 51 44 61 73, emmanuelle.reygagne-viera@ght85.fr
Emmanuelle REYGANE-VEYRA, MD
- Not yet recruiting
Centre de radiothérapie Guillaume le Conquérant
Le Havre
Romain MALLET, MD
Romain MALLET, MD
- Recruiting
Centre Oscar Lambret
Lille
David PASQUIER, MD, 33 5 56 43 70 12, d-pasquier@o-lambret.fr
David PASQUIER, MD
- Not yet recruiting
Centre Léon Bérard
Lyon
Laurence BAWWENS, MD
Laurence BAWWENS, MD
- Not yet recruiting
CHU La Timone
Marseille
Xavier MURACCIOLE, MD
Xavier MURACCIOLE, MD
- Not yet recruiting
Institut Paoli Calmette
Marseille
Naji SALEM, MD
Naji SALEM, MD
- Not yet recruiting
CHR
Metz
Xavier MICHEL, MD
Xavier MICHEL, MD
- Not yet recruiting
ICM
Montpellier
David AZRIA, PhD
David AZRIA, PhD
- Not yet recruiting
Institut de Cancérologie de Lorraine
Nancy
Anais STEFANI, MD
Anais STEFANI, MD
- Recruiting
Institut de Cancérologie de l'Ouest
Nantes
Stephane SUPIOT, MD
Stephane SUPIOT, MD
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Delphine BORCHIELLINI, MD, 33 4 92 03 15 14, Delphine.borchiellini@nice.unicancer.fr
Delphine BORCHIELLINI, MD
- Not yet recruiting
Centre Haute Energie
Nice
Audrey CLAREN-MERCATI, MD, audrey.claren@che-nice.com
Audrey CLAREN-MERCATI, MD
- Not yet recruiting
Institut Curie
Paris
CREHANGE Gilles, Pr
CREHANGE Gilles, Pr
- Not yet recruiting
Groupement de radiothérapie Oncologie des Pyrénées
Pau
GILLIOT Olivier, MD, 33 5 59 92 72 75, ogilliot@gmail.com
GILLIOT Olivier, MD
- Not yet recruiting
Centre Hospitalier Annecy Genevois
Pringy
CARBONNAUX Mélodie, MD, 33 4 50 58 52 55, mcarbonnaux@ch-annecygenevois.fr
CARBONNAUX Mélodie, MD
- Not yet recruiting
Centre Henri Becquerel
Rouen
Maximilien ROGE, MD, 33 2 32 08 24 70, maximilien.roge@chb.unicancer.fr
Maximilien ROGE, MD
- Not yet recruiting
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Etienne
Nicolas MAGNE, MD
Nicolas MAGNE, MD
- Recruiting
Polyclinique de l'Ormeau
Tarbes
Guillaume PEYRAGA, MD, dr.peyraga@grop65.fr
Guillaume PEYRAGA, MD
- Not yet recruiting
IUCT
Toulouse
Jonathan KHALIFA, MD
Jonathan KHALIFA, MD
- Recruiting
Centre marie Curie
Valence
Jean-Baptiste GUY, MD
Jean-Baptiste GUY, MD
- Recruiting
Institut Gustave Roussy
Villejuif
Mario TERLIZZI, MD
Mario TERLIZZI, MD
About this study
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.
Read more
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.
- Conditions
- Metastatic Renal Cell Carcinoma, Radiotherapy
- Being tested
- Steretactic radiotherapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steretactic radiotherapyRadiation
Steretactic radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Steretactic radiotherapy plus systemic treatment | Experimental | Not described Receives: Radiation: Steretactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 6 months post-randomization
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Until 1 month after end of treatment
Local control rate
Measured: 3, 6 and 12 months after randomization
Overall control rate
Measured: 3, 6 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Jul 2020
- Primary completionApr 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non randomized phase II trial
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, GETUG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299646
- Sponsor's protocol ID
- GETUG-StORM-01
- Acronym
- GETUG-StORM-01
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
- ClinicalTrials.gov ID
- NCT04299646
- Acronym / sponsor ID
- GETUG-StORM-01 / GETUG-StORM-01
- Conditions
- Metastatic Renal Cell Carcinoma, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, GETUG
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non randomized phase II trial
| Arm | Type | Receives |
|---|---|---|
| Steretactic radiotherapy plus systemic treatment | Experimental | Radiation: Steretactic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steretactic radiotherapySteretactic radiotherapy | Radiation | Steretactic radiotherapy plus systemic treatment |
Primary outcome
Progression-free survival
Time frame: 6 months post-randomization
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Until 1 month after end of treatment
Local control rate
Time frame: 3, 6 and 12 months after randomization
Overall control rate
Time frame: 3, 6 and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Steretactic radiotherapy in people with Metastatic Renal Cell Carcinoma and Radiotherapy, run by Centre Francois Baclesse at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazim KALHADI, MD (+ 332 31 45 50 50, n.khalladi@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.