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Using targeted radiotherapy for specific metastatic kidney cancer cases

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

PHASE2 · Centre Francois Baclesse · NCT04299646

This study is testing whether targeted radiotherapy can help people with advanced kidney cancer who have a few areas of growth while keeping the rest of their cancer under control.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment77 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Francois Baclesse (other)
Drugs / interventionsimmunotherapy, radiation
Locations30 sites (Albi and 29 other locations)
Trial IDNCT04299646 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with clear cell renal cancer who have oligoprogressive disease and are currently receiving systemic therapy.

Not a fit: Patients with widespread metastatic disease or those who do not meet the oligoprogressive criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve disease control and extend the duration of effective treatment for patients with oligoprogressive RCC.

How similar studies have performed: While RCC has traditionally been considered radioresistant, emerging studies suggest that targeted radiotherapy may offer new avenues for treatment, indicating potential success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Albi and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Renal Cell Carcinoma, Radiotherapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.