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New treatment option for Metastatic Renal Cell Carcinoma
Official title A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases
ClinicalTrials.gov ID: NCT04299646
What this study is testing
- What it's testing
- Every year, 12500 primary renal cell carcinoma (RCC) are diagnosed in France. Metastases occur in half of RCC patients.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Albi, France
- Angers, France
- Bordeaux, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- La Roche-sur-Yon, France
- Le Havre, France
- Lille, France
- Lyon, France
- Marseille, France
- Metz, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Pau, France
- Pringy, France
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albi, France; Angers, France; Bordeaux, France; Caen, France; Clermont-Ferrand, France; Créteil, France and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.