Stereotactic Radiotherapy for Renal Cancers

NCT02811250 | Completed DMC

• 2 other identifiers: 2009-5562010-A00087-32
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Renal Cancer

Keywords

Renal cancer; Stereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 .

  3 months after treatment

Study Arms (4)

Stereotactic radiotherapy 4 x 8 Gy

EXPERIMENTAL

Patient receive 4 stereotactic radiotherapy sessions with a dose of 8 Gy

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

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

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

Radiation: Stereotactic radiotherapy 4 x 12 Gy

Interventions

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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
• Participation in another ongoing study that may interfere with the present study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de Radiothérapie - Centre Georges François Leclerc

Dijon, 21079, France

Location

Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• 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.

  PMID: 35842186 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 23, 2016
• Study Start: October 1, 2010
• Primary Completion: February 1, 2018
• Study Completion: October 25, 2021
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)