Renal CancerRSR-1NCT02811250
Stereotactic Radiotherapy for Renal Cancers
A study testing Stereotactic radiotherapy 4 x 8 Gy, Stereotactic radiotherapy 5 x 8 Gy and Stereotactic radiotherapy 4 x 10 Gy in people with Renal Cancer, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Stereotactic radiotherapy 4 x 8 Gy, Stereotactic radiotherapy 5 x 8 Gy and Stereotactic radiotherapy 4 x 10 Gy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to 25 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged over 75 years with an operable renal tumor or patient with inoperable renal tumor irrespective of age, or patient with metastatic renal tumor and indication for nephrectomy.
- Histologically-confirmed Renal carcinoma less than or equal to 4 cm
- Tumor that is visible and measureable on abdominal scanner and/or MRI (Magnetic Resonance Imaging)
- Karnofsky performance status ≥ 60%
Who cannot join
- Patient with only one kidney and renal cancer
- Patient not able to cooperate during treatment
- Previous history of abdominal radiation therapy
- Tumor having infiltrated the renal pelvis
- Polycystic kidney disease
- Previous history of intestinal inflammatory disease such as ulcerative colitis or Crohn's disease
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- Renal insufficiency (creatinine clearance <30 ml/mm evaluated by DTPA (diethylenetriamine pentaacetic acid ) scintigraphy)
- Uncontrolled hypertension (SBP(systolic blood pressure) above 160 mmHg DBP(diastolic blood pressure) above 100 mmHg with antihypertensive treatment)
- Non primary lesions (benign lesions such as angiomyolipoma, renal metastases,…)
- Antineoplastic and/or antiangiogenic treatment in the month preceding radiotherapy
- Progressive cancer other than renal cancer at time of inclusion with the exception of in situ cervical carcinomas, basal cell carcinoma of the skin, and non-metastatic prostate cancer controlled without hormone therapy
- Participation in another ongoing study that may interfere with the present study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Radiothérapie - Centre Georges François Leclerc
Dijon, 21079
Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL
Pierre-Bénite, 69495
About this study
Official title: Stereotactic Radiotherapy for Renal Cancers: Phase I Study
Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery.
Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In Cleveland (USA) two phase I studies are already underway.
Read more
The investigators propose to develop a phase I study for tumors of less than 4 cm. As found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control.
The primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:
- Step 1: 4 x 8 Gy.
- Step 2: 5 x 8 Gy.
- Step 3: 4 x 10 Gy.
- Step 4: 4 x 12 Gy.
The patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.
- Conditions
- Renal Cancer
- Being tested
- Stereotactic radiotherapy 4 x 8 Gy, Stereotactic radiotherapy 5 x 8 Gy, Stereotactic radiotherapy 4 x 10 Gy, Stereotactic radiotherapy 4 x 12 Gy
- Keywords
- Renal cancer, Stereotactic radiotherapy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapy 4 x 8 GyRadiation
Stereotactic radiotherapy 5 x 8 GyRadiation
Stereotactic radiotherapy 4 x 10 GyRadiation
Stereotactic radiotherapy 4 x 12 GyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiotherapy 4 x 8 Gy | Experimental | Patient receive 4 stereotactic radiotherapy sessions with a dose of 8 Gy Receives: Radiation: Stereotactic radiotherapy 4 x 8 Gy |
| Stereotactic radiotherapy 5 x 8 Gy | Experimental | Patient receive 5 stereotactic radiotherapy sessions with a dose of 8 Gy Receives: Radiation: Stereotactic radiotherapy 5 x 8 Gy |
| Stereotactic radiotherapy 4 x 10 Gy | Experimental | Patient receive 4 stereotactic radiotherapy sessions with a dose of 10 Gy Receives: Radiation: Stereotactic radiotherapy 4 x 10 Gy |
| Stereotactic radiotherapy 4 x 12 Gy | Experimental | Patient receive 4 stereotactic radiotherapy sessions with a dose of 12 Gy Receives: Radiation: Stereotactic radiotherapy 4 x 12 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of grade ≥ 4 toxicity
The primary outcome is the occurrence of grade ≥ 4 toxicity according to CTCAE version 4 (Common Terminology Criteria for Adverse Events) during treatment and in the 3 months after end of treatment .
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startOct 2010
- Primary completionFeb 2018
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811250
- Sponsor's protocol ID
- 2009-556
- Other IDs
- 2010-A00087-32
- Acronym
- RSR-1
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2016
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lapierre A, Badet L, Rouviere O, Crehange G, Berthiller J, Paparel P, Chapet O. Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Cancer: 24-Month Results of the RSR1 Phase 1 Dose Escalation Study. Pract Radiat Oncol. 2023 Jan-Feb;13(1):e73-e79. doi: 10.1016/j.prro.2022.06.012. Epub 2022 Jul 14.
PubMed 35842186
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiotherapy for Renal Cancers: Phase I Study
- ClinicalTrials.gov ID
- NCT02811250
- Acronym / sponsor ID
- RSR-1 / 2009-556
- Conditions
- Renal Cancer
- Keywords
- Renal cancer, Stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery.
Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In Cleveland (USA) two phase I studies are already underway.
The investigators propose to develop a phase I study for tumors of less than 4 cm. As found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control.
The primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:
- Step 1: 4 x 8 Gy.
- Step 2: 5 x 8 Gy.
- Step 3: 4 x 10 Gy.
- Step 4: 4 x 12 Gy.
The patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiotherapy 4 x 8 Gy | Experimental | Radiation: Stereotactic radiotherapy 4 x 8 GyPatient receive 4 stereotactic radiotherapy sessions with a dose of 8 Gy |
| Stereotactic radiotherapy 5 x 8 Gy | Experimental | Radiation: Stereotactic radiotherapy 5 x 8 GyPatient receive 5 stereotactic radiotherapy sessions with a dose of 8 Gy |
| Stereotactic radiotherapy 4 x 10 Gy | Experimental | Radiation: Stereotactic radiotherapy 4 x 10 GyPatient receive 4 stereotactic radiotherapy sessions with a dose of 10 Gy |
| Stereotactic radiotherapy 4 x 12 Gy | Experimental | Radiation: Stereotactic radiotherapy 4 x 12 GyPatient receive 4 stereotactic radiotherapy sessions with a dose of 12 Gy |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient aged over 75 years with an operable renal tumor or patient with inoperable renal tumor irrespective of age, or patient with metastatic renal tumor and indication for nephrectomy.
- Histologically-confirmed Renal carcinoma less than or equal to 4 cm
- Tumor that is visible and measureable on abdominal scanner and/or MRI (Magnetic Resonance Imaging)
- Karnofsky performance status ≥ 60%
Key exclusion criteria (12 listed)
- Patient with only one kidney and renal cancer
- Patient not able to cooperate during treatment
- Previous history of abdominal radiation therapy
- Tumor having infiltrated the renal pelvis
- Polycystic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiotherapy 4 x 8 Gy | Radiation | Stereotactic radiotherapy 4 x 8 Gy |
| Stereotactic radiotherapy 5 x 8 Gy | Radiation | Stereotactic radiotherapy 5 x 8 Gy |
| Stereotactic radiotherapy 4 x 10 Gy | Radiation | Stereotactic radiotherapy 4 x 10 Gy |
| Stereotactic radiotherapy 4 x 12 Gy | Radiation | Stereotactic radiotherapy 4 x 12 Gy |
Primary outcome
Occurrence of grade ≥ 4 toxicity
Time frame: 3 months after treatment
The primary outcome is the occurrence of grade ≥ 4 toxicity according to CTCAE version 4 (Common Terminology Criteria for Adverse Events) during treatment and in the 3 months after end of treatment .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 35842186Lapierre A, Badet L, Rouviere O, Crehange G, Berthiller J, Paparel P, Chapet O. Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Cancer: 24-Month Results of the RSR1 Phase 1 Dose Escalation Study. Pract Radiat Oncol. 2023 Jan-Feb;13(1):e73-e79. doi: 10.1016/j.prro.2022.06.012. Epub 2022 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiotherapy 4 x 8 Gy, Stereotactic radiotherapy 5 x 8 Gy and Stereotactic radiotherapy 4 x 10 Gy in people with Renal Cancer, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of grade ≥ 4 toxicity (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.