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

Primary Purpose

Metastatic Renal Cell Carcinoma, Radiotherapy

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Steretactic radiotherapy
Pursuit of ongoing systemic treatment
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Claude Bernard
  • Institut de Cancérologie de l'Ouest
  • Institut Bergonié
  • Radiothérapie Bordeaux Nord Aquitaine
  • Centre François BaclesseRecruiting
  • Centre Jean Perrin
  • CHU Henri Mondor
  • Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
  • Centre Léon Bérard
  • CHU La Timone
  • ICM
  • Institut de Cancérologie de Lorraine
  • Institut de Cancérologie de l'Ouest
  • Centre Haute Energie
  • Institut Curie
  • Institut de Cancérologie de la Loire Lucien Neuwirth
  • IUCT
  • Centre marie Curie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steretactic radiotherapy plus systemic treatment

Systemic treatment

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Local control rate
Overall control rate

Full Information

First Posted
March 2, 2020
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
Collaborators
National Cancer Institute, France, GETUG
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1. Study Identification

Unique Protocol Identification Number
NCT04299646
Brief Title
Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Acronym
GETUG-StORM-01
Official Title
A Randomized Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
National Cancer Institute, France, GETUG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized 2:1 phase II trial
Masking
Participant
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steretactic radiotherapy plus systemic treatment
Arm Type
Experimental
Arm Title
Systemic treatment
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Steretactic radiotherapy
Intervention Description
Steretactic radiotherapy
Intervention Type
Drug
Intervention Name(s)
Pursuit of ongoing systemic treatment
Intervention Description
Pursuit of ongoing systemic treatment
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months post-randomization
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Until 1 month after end of treatment
Title
Local control rate
Time Frame
3, 6 and 12 months after randomization
Title
Overall control rate
Time Frame
3, 6 and 12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel MEYER, MD
Phone
+ 332 31 45 50 20
Email
e.meyer@mail.baclesse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel GRELLARD
Phone
+33 2 31 45 50 02
Email
jm.grellard@baclesse.unicancer.fr
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent VOTRON, MD
First Name & Middle Initial & Last Name & Degree
Laurent VOTRON, MD
First Name & Middle Initial & Last Name & Degree
Claude ALZIEU, MD
First Name & Middle Initial & Last Name & Degree
Pierre AUBERDIAC, MD
First Name & Middle Initial & Last Name & Degree
Yan BERGE, MD
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémy COLLIAUX, MD
First Name & Middle Initial & Last Name & Degree
Jérémy COLLIAUX, MD
First Name & Middle Initial & Last Name & Degree
Nathalie MESGOUEZ-NEBOUT, MD
First Name & Middle Initial & Last Name & Degree
Hadji HAMIDOU, MD
First Name & Middle Initial & Last Name & Degree
Thibaut LIZEE, MD
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline GILLON, MD
First Name & Middle Initial & Last Name & Degree
Pauline GILLON, MD
Facility Name
Radiothérapie Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigolène GALLAND-GIRODET, MD
First Name & Middle Initial & Last Name & Degree
Sigolène GALLAND-GIRODET, MD
First Name & Middle Initial & Last Name & Degree
François GUICHARD, MD
First Name & Middle Initial & Last Name & Degree
Bénédicte HENRIQUES, MD
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel MEYER, MD
Phone
+33 2 31 45 50 20
Email
e.meyer@mail.baclesse.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel jm.grellard@baclesse.unicancer.fr
Phone
+33 2 31 45 50 02
Email
jm.grellard@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel MEYER, MD
First Name & Middle Initial & Last Name & Degree
Florence JOLY, PhD
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel BRACHET, MD
First Name & Middle Initial & Last Name & Degree
Elodie COQUAN, MD
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genevieve LOOS, MD
First Name & Middle Initial & Last Name & Degree
Genevieve LOOS, MD
First Name & Middle Initial & Last Name & Degree
Hakim MAHAMMEDI, MD
First Name & Middle Initial & Last Name & Degree
Jessica MIROIR, MD
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yacid BELKACEMI, MD
First Name & Middle Initial & Last Name & Degree
Yacid BELKACEMI, MD
First Name & Middle Initial & Last Name & Degree
Gabriele CORAGGIO, MD
Facility Name
Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis LEPINOY, MD
First Name & Middle Initial & Last Name & Degree
Alexis LEPINOY, MD
First Name & Middle Initial & Last Name & Degree
Benjamin SCHIPMAN, MD
First Name & Middle Initial & Last Name & Degree
Véronique LORGIS, MD
First Name & Middle Initial & Last Name & Degree
Nicolas LESCUT, MD
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji SALEM, MD
First Name & Middle Initial & Last Name & Degree
Naji SALEM, MD
First Name & Middle Initial & Last Name & Degree
Gwenaëlle GRAVIS, MD
First Name & Middle Initial & Last Name & Degree
Cécile VICIER, MD
First Name & Middle Initial & Last Name & Degree
Mathilde GUERIN, MD
First Name & Middle Initial & Last Name & Degree
Slimane DERMECHE, MD
First Name & Middle Initial & Last Name & Degree
Géraldine PIGNOT, MD
First Name & Middle Initial & Last Name & Degree
Jochen WALZ, MD
Facility Name
CHU La Timone
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier MURACCIOLE, MD
First Name & Middle Initial & Last Name & Degree
Xavier MURACCIOLE, MD
First Name & Middle Initial & Last Name & Degree
Eric LECHEVALLIER, MD
First Name & Middle Initial & Last Name & Degree
Gilles KARSENTY, MD
First Name & Middle Initial & Last Name & Degree
Jean-Laurent DEVILLE, MD
First Name & Middle Initial & Last Name & Degree
veronique DELAPORTE, MD
Facility Name
ICM
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David AZRIA, PhD
First Name & Middle Initial & Last Name & Degree
David AZRIA, PhD
First Name & Middle Initial & Last Name & Degree
Marie CHARISSOUX, MD
First Name & Middle Initial & Last Name & Degree
Diego TOSI, MD
First Name & Middle Initial & Last Name & Degree
Carmen LLACER-MOSCARDO, MD
First Name & Middle Initial & Last Name & Degree
Marie VIALA, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anais STEFANI, MD
First Name & Middle Initial & Last Name & Degree
Anais STEFANI, MD
First Name & Middle Initial & Last Name & Degree
Anne-Sophie BAUMANN, MD
First Name & Middle Initial & Last Name & Degree
Jean-François PY, MD
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane SUPIOT, MD
First Name & Middle Initial & Last Name & Degree
Stephane SUPIOT, MD
First Name & Middle Initial & Last Name & Degree
Valentine GUIMAS, MD
First Name & Middle Initial & Last Name & Degree
Vincent LIBOIS, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel RIO, MD
Facility Name
Centre Haute Energie
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René Jean BENSADOUN, PhD
First Name & Middle Initial & Last Name & Degree
René Jean BENSADOUN, PhD
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar Line KRHLI, MD
First Name & Middle Initial & Last Name & Degree
Samar Line KRHLI, MD
First Name & Middle Initial & Last Name & Degree
Gilles CREHANGE, MD
First Name & Middle Initial & Last Name & Degree
Mathieu MINSAT, MD
First Name & Middle Initial & Last Name & Degree
Thomas FREDERIC MOREAU, MD
Facility Name
Institut de Cancérologie de la Loire Lucien Neuwirth
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE, MD
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE, MD
First Name & Middle Initial & Last Name & Degree
Julien LANGRAND-ESCURE, MD
First Name & Middle Initial & Last Name & Degree
Alexis VALLARD, MD
First Name & Middle Initial & Last Name & Degree
Jane-Chloé TRONE, MD
First Name & Middle Initial & Last Name & Degree
Grégoire PIGNE, MD
Facility Name
IUCT
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre GRAFF-CAILLEAUD, MD
First Name & Middle Initial & Last Name & Degree
Pierre GRAFF-CAILLEAUD, MD
First Name & Middle Initial & Last Name & Degree
Jonathan KHALIFA, MD
Facility Name
Centre marie Curie
City
Valence
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste GUY, MD
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste GUY, MD
First Name & Middle Initial & Last Name & Degree
Emilie BONNET, MD
First Name & Middle Initial & Last Name & Degree
Bertrand FLEURY, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases

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