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

July 31, 2023 updated by: Centre Francois Baclesse

A Randomized Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • 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 Backup

Study Locations

  • France
      • Albi, France
        • Not yet recruiting
        • Clinique Claude Bernard
        • Contact:
          • Laurent VOTRON, MD
        • Sub-Investigator:
          • Claude ALZIEU, MD
        • Sub-Investigator:
          • Pierre AUBERDIAC, MD
        • Sub-Investigator:
          • Yan BERGE, MD
        • Principal Investigator:
          • Laurent Votron, MD
      • Angers, France
        • Not yet recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
          • Jérémy COLLIAUX, MD
        • Principal Investigator:
          • Jérémy COLLIAUX, MD
        • Sub-Investigator:
          • Nathalie MESGOUEZ-NEBOUT, MD
        • Sub-Investigator:
          • Hadji HAMIDOU, MD
        • Sub-Investigator:
          • Thibaut LIZEE, MD
      • Bordeaux, France
        • Not yet recruiting
        • Institut Bergonié
        • Contact:
          • Pauline GILLON, MD
        • Principal Investigator:
          • Pauline GILLON, MD
      • Bordeaux, France
        • Not yet recruiting
        • Radiothérapie Bordeaux Nord Aquitaine
        • Contact:
          • Sigolène GALLAND-GIRODET, MD
        • Sub-Investigator:
          • François GUICHARD, MD
        • Sub-Investigator:
          • Bénédicte HENRIQUES, MD
        • Principal Investigator:
          • Sigolène Galland-Girodet, MD
      • Caen, France, 14076
        • Recruiting
        • Centre François Baclesse
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuel MEYER, MD
        • Sub-Investigator:
          • Florence JOLY, PhD
        • Sub-Investigator:
          • Elodie COQUAN, MD
        • Sub-Investigator:
          • Pierre-Emmanuel BRACHET, MD
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Jean Perrin
        • Contact:
          • Genevieve LOOS, MD
        • Principal Investigator:
          • Genevieve LOOS, MD
        • Sub-Investigator:
          • Hakim MAHAMMEDI, MD
        • Sub-Investigator:
          • Jessica MIROIR, MD
      • Créteil, France
        • Not yet recruiting
        • CHU Henri Mondor
        • Contact:
          • Yacid BELKACEMI, MD
        • Principal Investigator:
          • Yacid BELKACEMI, MD
        • Sub-Investigator:
          • Gabriele CORAGGIO, MD
      • Dijon, France
        • Not yet recruiting
        • Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
        • Contact:
          • Alexis LEPINOY, MD
        • Principal Investigator:
          • Alexis LEPINOY, MD
        • Sub-Investigator:
          • Benjamin SCHIPMAN, MD
        • Sub-Investigator:
          • Véronique LORGIS, MD
        • Sub-Investigator:
          • Nicolas LESCUT, MD
      • Lyon, France
        • Not yet recruiting
        • Centre Léon Bérard
        • Contact:
          • Naji SALEM, MD
        • Principal Investigator:
          • Naji SALEM, MD
        • Sub-Investigator:
          • Gwenaëlle GRAVIS, MD
        • Sub-Investigator:
          • Cécile VICIER, MD
        • Sub-Investigator:
          • Mathilde GUERIN, MD
        • Sub-Investigator:
          • Slimane DERMECHE, MD
        • Sub-Investigator:
          • Géraldine PIGNOT, MD
        • Sub-Investigator:
          • Jochen Walz, MD
      • Marseille, France
        • Not yet recruiting
        • CHU La Timone
        • Contact:
          • Xavier MURACCIOLE, MD
        • Principal Investigator:
          • Xavier MURACCIOLE, MD
        • Sub-Investigator:
          • Eric LECHEVALLIER, MD
        • Sub-Investigator:
          • Gilles KARSENTY, MD
        • Sub-Investigator:
          • Jean-Laurent DEVILLE, MD
        • Sub-Investigator:
          • veronique DELAPORTE, MD
      • Montpellier, France
        • Not yet recruiting
        • ICM
        • Contact:
          • David AZRIA, PhD
        • Principal Investigator:
          • David AZRIA, PhD
        • Sub-Investigator:
          • Diego TOSI, MD
        • Sub-Investigator:
          • Carmen LLACER-MOSCARDO, MD
        • Sub-Investigator:
          • Marie CHARISSOUX, MD
        • Sub-Investigator:
          • Marie VIALA, MD
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine
        • Sub-Investigator:
          • Jean-François PY, MD
        • Contact:
          • Anais STEFANI, MD
        • Principal Investigator:
          • ANAIS STEFANI, MD
        • Sub-Investigator:
          • Anne-Sophie BAUMANN, MD
      • Nantes, France
        • Not yet recruiting
        • Institut de Cancérologie de l'Ouest
        • Sub-Investigator:
          • Valentine GUIMAS, MD
        • Sub-Investigator:
          • Vincent LIBOIS, MD
        • Sub-Investigator:
          • Emmanuel RIO, MD
        • Contact:
          • Stéphane SUPIOT, MD
        • Principal Investigator:
          • Stéphane Supiot, MD
      • Nice, France
        • Not yet recruiting
        • Centre Haute Energie
        • Contact:
          • René Jean BENSADOUN, PhD
        • Principal Investigator:
          • René Jean BENSADOUN, PhD
      • Paris, France
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Samar Line KRHLI, MD
        • Principal Investigator:
          • Samar Line KRHLI, MD
        • Sub-Investigator:
          • Gilles CREHANGE, MD
        • Sub-Investigator:
          • Mathieu MINSAT, MD
        • Sub-Investigator:
          • Thomas FREDERIC MOREAU, MD
      • Saint-Étienne, France
        • Not yet recruiting
        • Institut de Cancérologie de la Loire Lucien Neuwirth
        • Sub-Investigator:
          • Alexis VALLARD, MD
        • Sub-Investigator:
          • Julien LANGRAND-ESCURE, MD
        • Contact:
          • Nicolas MAGNE, MD
        • Principal Investigator:
          • Nicolas MAGNE, MD
        • Sub-Investigator:
          • Jane-Chloé TRONE, MD
        • Sub-Investigator:
          • Grégoire PIGNE, MD
      • Toulouse, France
        • Not yet recruiting
        • IUCT
        • Contact:
          • Pierre GRAFF-CAILLEAUD, MD
        • Sub-Investigator:
          • Jonathan KHALIFA, MD
        • Principal Investigator:
          • Pierre Graff-Cailleaud, MD
      • Valence, France
        • Not yet recruiting
        • Centre Marie Curie
        • Contact:
          • Jean-Baptiste GUY, MD
        • Sub-Investigator:
          • Emilie BONNET, MD
        • Sub-Investigator:
          • Bertrand FLEURY, MD
        • Principal Investigator:
          • Jean-Baptiste GUY, 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steretactic radiotherapy plus systemic treatment
Radiation: Steretactic radiotherapy
Steretactic radiotherapy
Drug: Pursuit of ongoing systemic treatment
Pursuit of ongoing systemic treatment
Active Comparator: Systemic treatment
Drug: Pursuit of ongoing systemic treatment
Pursuit of ongoing systemic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 6 months post-randomization
6 months post-randomization

Secondary Outcome Measures

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

Centre Francois Baclesse

Collaborators

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)

July 1, 2020

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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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