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Taking people in FrancePhase 2

Tests stereotactic radiotherapy for kidney cancer that grows at a few sites

Tests focused radiation on a few growing spots in adults with metastatic kidney cancer.

Key facts

Who runs it
Centre Francois Baclesse
Where
Albi, Angers, Bordeaux, Caen, Clermont-Ferrand, Créteil, Dijon, La Roche-sur-Yon, LE HAVRE, Lille, Lyon, Marseille, Metz, Montpellier, Nancy, Nantes, Nice, Paris, Pau, Pringy, Rouen, Saint-Etienne, Tarbes, Toulouse, Valence, and Villejuif, FranceSee the 30 sites
Trial code
Registry title
A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Status
Recruiting
Phase
Phase 2
People taking part
77 people, planned
Started
1 Jul 2020
Expected to end
Aug 2029
Type of study
Interventional
Treatments tested
  • Steretactic radiotherapy
Record updated
13 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metastatic clear cell kidney cancer who are on first or second line systemic treatment and have only 1 to 3 growing metastases that can be treated with stereotactic radiotherapy.

Age
18 years or older
Sex
All sexes can join
Disease stage
Metastatic clear cell renal cell carcinoma outside the brain, with oligoprogression: 1 to 3 progressing metastases in up to 2 organs, confirmed on 2 CT scans 2 months apart. At least one progressing metastasis can be measured, and all progressing lesions are 4 cm (1.6 in) or smaller.
Earlier treatment
Currently on first or second line systemic treatment (targeted therapy and/or immunotherapy). People with 3 or more lines of systemic therapy, or with previous radiotherapy on a target lesion, cannot join.

Main reasons for not taking part

  • More than 3 progressing metastases
  • Brain metastases
  • A progressing metastasis that cannot all be treated with stereotactic radiotherapy
  • Another cancer diagnosed within the last 5 years
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who received 3 or more lines of systemic therapy
  • Previous radiation therapy performed in ≥ 1 target lesion
  • At least 1 progressive metastasis requiring surgical treatment
  • Non measurable disease according R.E.C.I.S.T. criteria
  • Current or past history of second neoplasm diagnosed within the last 5 years
  • More than 3 progressive metastases
  • Inability to treat all progressive metastatic sites with SRT
  • 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
  • Pregnancy or breast feeding or inadequate contraceptive measures
  • Patients who cannot be adequately followed up
  • Patient deprived of freedom or under guardianship

Where in France

  • Clinique Claude BernardAlbi, FranceContact: Laurent VOTRON, MDNot yet recruiting
  • Institut de Cancerologie de L'OuestAngers, FranceContact: Jérémy COLLIAUX, MDTaking people
  • Institut BergonieBordeaux, FranceContact: Paul SARGOS, MDNot yet recruiting
  • Radiothérapie Bordeaux Nord AquitaineBordeaux, FranceContact: Sigolène GALLAND-GIRODET, MDNot yet recruiting
  • Centre François BaclesseCaen, FranceContact: Nazim KHALLADI, MDTaking people
  • Centre Jean PerrinClermont-Ferrand, FranceContact: Jessica MIROIR, MDNot yet recruiting
  • CHU Henri MondorCréteil, FranceContact: Yacid BELKACEMI, MDNot yet recruiting
  • Centre Georges François LeclercDijon, FranceContact: Magali QUIVRIN, MDNot yet recruiting
  • Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)Dijon, FranceContact: Alexis LEPINOY, MDTaking people
  • CHD VendéeLa Roche-sur-Yon, FranceContact: Emmanuelle REYGANE-VEYRA, MDNot yet recruiting
  • Centre de Radiothérapie Guillaume le ConquérantLE HAVRE, FranceContact: Romain MALLET, MDNot yet recruiting
  • Centre Oscar LambretLille, FranceContact: David PASQUIER, MDTaking people
  • Centre Leon BerardLyon, FranceContact: Laurence BAWWENS, MDNot yet recruiting
  • CHU La TimoneMarseille, FranceContact: Xavier MURACCIOLE, MDNot yet recruiting
  • Institut Paoli-CalmetteMarseille, FranceContact: Naji SALEM, MDNot yet recruiting
  • CHRMetz, FranceContact: Xavier MICHEL, MDNot yet recruiting
  • ICMMontpellier, FranceContact: David AZRIA, PhDNot yet recruiting
  • Institut de cancérologie de LorraineNancy, FranceContact: Anais STEFANI, MDNot yet recruiting
  • Institut de Cancérologie de l'OuestNantes, FranceContact: Stephane SUPIOT, MDTaking people
  • Centre Antoine LacassagneNice, FranceContact: Delphine BORCHIELLINI, MDNot yet recruiting
  • Centre Haute EnergieNice, FranceContact: Audrey CLAREN-MERCATI, MDNot yet recruiting
  • Institut CurieParis, FranceContact: CREHANGE Gilles, PrNot yet recruiting
  • Groupement de radiothérapie Oncologie des PyrénéesPau, FranceContact: GILLIOT Olivier, MDNot yet recruiting
  • Centre Hospitalier Annecy GenevoisPringy, FranceContact: CARBONNAUX Mélodie, MDNot yet recruiting
  • Centre Henri BecquerelRouen, FranceContact: Maximilien ROGE, MDNot yet recruiting
  • Institut de Cancérologie de la Loire Lucien NeuwirthSaint-Etienne, FranceContact: Nicolas MAGNE, MDNot yet recruiting
  • Polyclinique de l'OrmeauTarbes, FranceContact: Guillaume PEYRAGA, MDTaking people
  • IUCTToulouse, FranceContact: Jonathan KHALIFA, MDNot yet recruiting
  • Centre Marie CurieValence, FranceContact: Jean-Baptiste GUY, MDTaking people
  • Institut Gustave RoussyVillejuif, FranceContact: Mario TERLIZZI, MDTaking people

About the trial

What the trial wants to find out

Every year, 12500 primary renal cell carcinoma (RCC) are diagnosed in France. Metastases occur in half of RCC patients.

Read full original descriptionShow less

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.

The group in the trial

  • Steretactic radiotherapy plus systemic treatmentTreatment being tested

    Treatment: Steretactic radiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Plain-language title
Tests stereotactic radiotherapy for kidney cancer that grows at a few sitesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 January 2026