Stereotactic Radiotherapy for Renal Cancers (RSR-1)

March 13, 2023 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Service de Radiothérapie - Centre Georges François Leclerc
      • Pierre Bénite, France, 69495
        • Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic radiotherapy 4 x 8 Gy
Patient receive 4 stereotactic radiotherapy sessions with a dose of 8 Gy
Radiation: Stereotactic radiotherapy 4 x 8 Gy
Experimental: Stereotactic radiotherapy 5 x 8 Gy
Patient receive 5 stereotactic radiotherapy sessions with a dose of 8 Gy
Radiation: Stereotactic radiotherapy 5 x 8 Gy
Experimental: Stereotactic radiotherapy 4 x 10 Gy
Patient receive 4 stereotactic radiotherapy sessions with a dose of 10 Gy
Radiation: Stereotactic radiotherapy 4 x 10 Gy
Experimental: Stereotactic radiotherapy 4 x 12 Gy
Patient receive 4 stereotactic radiotherapy sessions with a dose of 12 Gy
Radiation: Stereotactic radiotherapy 4 x 12 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

October 25, 2021

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-556
  • 2010-A00087-32 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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