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

Launched by CENTRE FRANCOIS BACLESSE · Mar 6, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called stereotactic radiotherapy (SRT) for patients with metastatic renal cell carcinoma (RCC) who are experiencing a specific type of disease progression known as oligoprogressive disease. This means that while most of the cancer is under control, one to three metastatic spots are getting worse. The goal of the trial is to see if using SRT on these growing spots can help control the disease better while allowing patients to continue their current systemic treatments, which are medications that target cancer throughout the body.

To be eligible for this trial, participants need to have clear cell renal cancer that has been confirmed by a doctor and should have a limited number of progressive metastases. They should be receiving first or second-line systemic treatments and be in good overall health. Participants will receive SRT for their progressing spots and will be monitored to see how well the treatment works. This trial is important because while there have been promising results from previous studies, this is the first time researchers will systematically evaluate SRT for this specific situation, which could lead to better treatment options for patients with oligoprogressive metastatic RCC.

Gender

ALL

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