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

RecruitingPhase 2Ages 18 Years - anyAllCentre Francois Baclesse
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In plain words

What the trial is, and whether it could suit you

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 radioresist

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Steretactic radiotherapy
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Where

30 sites
Clinique Claude Bernard
Albi, France
Institut de Cancérologie de l'Ouest
Angers, France
Institut Bergonié
Bordeaux, France
Radiothérapie Bordeaux Nord Aquitaine
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
CHU Henri Mondor
Créteil, France
Centre Georges François LECLERC
Dijon, France

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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