Status:
RECRUITING
A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
National Cancer Institute, France
GETUG
Conditions:
Metastatic Renal Cell Carcinoma
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 therapie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04299646
Start Date
July 1 2020
End Date
January 1 2026
Last Update
July 2 2025
Active Locations (31)
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1
Clinique Claude Bernard
Albi, France
2
Institut de Cancérologie de l'Ouest
Angers, France
3
Institut Bergonié
Bordeaux, France
4
Radiothérapie Bordeaux Nord Aquitaine
Bordeaux, France