A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases (GETUG-StORM-01)

January 12, 2026 updated by: Centre Francois Baclesse

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Albi, France
        • Not yet recruiting
        • Clinique Claude Bernard
        • Contact:
          • Laurent VOTRON, MD
        • Principal Investigator:
          • Laurent VOTRON, MD
      • Angers, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Jérémy COLLIAUX, MD
        • Principal Investigator:
          • Jérémy COLLIAUX, MD
      • Bordeaux, France
        • Not yet recruiting
        • Institut Bergonie
        • Contact:
          • Paul SARGOS, MD
        • Principal Investigator:
          • Paul SARGOS, MD
      • Bordeaux, France
        • Not yet recruiting
        • Radiothérapie Bordeaux Nord Aquitaine
        • Contact:
          • Sigolène GALLAND-GIRODET, MD
        • Principal Investigator:
          • Sigolène GALLAND-GIRODET, MD
      • Caen, France, 14076
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Jean Perrin
        • Contact:
          • Jessica MIROIR, MD
        • Principal Investigator:
          • Jessica MIROIR, MD
      • Créteil, France
        • Not yet recruiting
        • Chu Henri Mondor
        • Contact:
          • Yacid BELKACEMI, MD
        • Principal Investigator:
          • Yacid BELKACEMI, MD
      • Dijon, France
        • Not yet recruiting
        • Centre Georges Francois Leclerc
        • Principal Investigator:
          • Magali QUIVRIN, MD
        • Contact:
      • Dijon, France
        • Recruiting
        • Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
        • Contact:
          • Alexis LEPINOY, MD
        • Principal Investigator:
          • Alexis LEPINOY, MD
      • La Roche-sur-Yon, France
        • Not yet recruiting
        • CHD Vendée
        • Contact:
        • Principal Investigator:
          • Emmanuelle REYGANE-VEYRA, MD
      • Le Havre, France
        • Not yet recruiting
        • Centre De Radiothérapie Guillaume Le Conquérant
        • Contact:
          • Romain MALLET, MD
        • Principal Investigator:
          • Romain MALLET, MD
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • David PASQUIER, MD
        • Contact:
      • Lyon, France
        • Not yet recruiting
        • Centre Leon Berard
        • Contact:
          • Laurence BAWWENS, MD
        • Principal Investigator:
          • Laurence BAWWENS, MD
      • Marseille, France
        • Not yet recruiting
        • Institut Paoli Calmette
        • Contact:
          • Naji SALEM, MD
        • Principal Investigator:
          • Naji SALEM, MD
      • Marseille, France
        • Not yet recruiting
        • CHU La Timone
        • Contact:
          • Xavier MURACCIOLE, MD
        • Principal Investigator:
          • Xavier MURACCIOLE, MD
      • Metz, France
        • Not yet recruiting
        • CHR
        • Principal Investigator:
          • Xavier MICHEL, MD
        • Contact:
          • Xavier MICHEL, MD
      • Montpellier, France
        • Not yet recruiting
        • ICM
        • Contact:
          • David AZRIA, PhD
        • Principal Investigator:
          • David AZRIA, PhD
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Anais STEFANI, MD
        • Principal Investigator:
          • Anais STEFANI, MD
      • Nantes, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Stephane SUPIOT, MD
        • Principal Investigator:
          • Stephane SUPIOT, MD
      • Nice, France
        • Not yet recruiting
        • Centre Antoine Lacassagne
        • Principal Investigator:
          • Delphine BORCHIELLINI, MD
        • Contact:
      • Nice, France
        • Not yet recruiting
        • Centre Haute Energie
        • Contact:
        • Principal Investigator:
          • Audrey CLAREN-MERCATI, MD
      • Paris, France
        • Not yet recruiting
        • Institut Curie
        • Principal Investigator:
          • CREHANGE Gilles, Pr
        • Contact:
          • CREHANGE Gilles, Pr
      • Pau, France
        • Not yet recruiting
        • Groupement de radiothérapie Oncologie des Pyrénées
        • Contact:
        • Principal Investigator:
          • GILLIOT Olivier, MD
      • Pringy, France
        • Not yet recruiting
        • Centre Hospitalier Annecy Genevois
        • Contact:
        • Principal Investigator:
          • CARBONNAUX Mélodie, MD
      • Rouen, France
        • Not yet recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Maximilien ROGE, MD
        • Contact:
      • Saint-Etienne, France
        • Not yet recruiting
        • Institut de Cancérologie de la Loire Lucien Neuwirth
        • Contact:
          • Nicolas MAGNE, MD
        • Principal Investigator:
          • Nicolas MAGNE, MD
      • Tarbes, France
        • Recruiting
        • Polyclinique de l'Ormeau
        • Contact:
        • Principal Investigator:
          • Guillaume PEYRAGA, MD
      • Toulouse, France
        • Not yet recruiting
        • IUCT
        • Contact:
          • Jonathan KHALIFA, MD
        • Principal Investigator:
          • Jonathan KHALIFA, MD
      • Valence, France
        • Recruiting
        • Centre Marie Curie
        • Contact:
          • Jean-Baptiste GUY, MD
        • Principal Investigator:
          • Jean-Baptiste GUY, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Mario TERLIZZI, MD
        • Principal Investigator:
          • Mario TERLIZZI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Steretactic radiotherapy plus systemic treatment
Radiation: Steretactic radiotherapy
Steretactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival
Time Frame: 6 months post-randomization
6 months post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Until 1 month after end of treatment
Until 1 month after end of treatment
Local control rate
Time Frame: 3, 6 and 12 months after randomization
3, 6 and 12 months after randomization
Overall control rate
Time Frame: 3, 6 and 12 months after randomization
3, 6 and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Francois Baclesse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute, France
GETUG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETUG-StORM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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