Using targeted radiotherapy for specific metastatic kidney cancer cases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the effectiveness of stereotactic radiotherapy in patients with oligoprogressive metastatic renal cell carcinoma (RCC). The study focuses on patients who have shown progression in 1 to 3 metastatic sites while maintaining control over the rest of their cancer. By applying ablative treatments to these specific sites, the trial aims to prolong the effectiveness of ongoing systemic therapies and delay the need for additional treatments. Participants will be monitored through imaging to assess the response to the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut de Cancérologie de l'Ouest
  Angers, France Recruiting
• Centre François Baclesse
  Caen, France Recruiting
• Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
  Dijon, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Institut de Cancérologie de l'Ouest
  Nantes, France Recruiting
• Polyclinique de l'Ormeau
  Tarbes, France Recruiting

Study contacts

• Study coordinator: Nazim KALHADI, MD
• Email: n.khalladi@baclesse.unicancer.fr
• Phone: + 332 31 45 50 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.