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Stereotactic Radiotherapy for Renal Cancers (RSR-1)

Primary Purpose

Renal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stereotactic radiotherapy 4 x 8 Gy
Stereotactic radiotherapy 5 x 8 Gy
Stereotactic radiotherapy 4 x 10 Gy
Stereotactic radiotherapy 4 x 12 Gy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring Renal cancer, Stereotactic radiotherapy

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Radiothérapie - Centre Georges François Leclerc
  • Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stereotactic radiotherapy 4 x 8 Gy

Stereotactic radiotherapy 5 x 8 Gy

Stereotactic radiotherapy 4 x 10 Gy

Stereotactic radiotherapy 4 x 12 Gy

Arm Description

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

Patient receive 5 stereotactic radiotherapy sessions with a dose of 8 Gy

Patient receive 4 stereotactic radiotherapy sessions with a dose of 10 Gy

Patient receive 4 stereotactic radiotherapy sessions with a dose of 12 Gy

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
June 8, 2016
Last Updated
March 13, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02811250
Brief Title
Stereotactic Radiotherapy for Renal Cancers
Acronym
RSR-1
Official Title
Stereotactic Radiotherapy for Renal Cancers: Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
Renal cancer, Stereotactic radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic radiotherapy 4 x 8 Gy
Arm Type
Experimental
Arm Description
Patient receive 4 stereotactic radiotherapy sessions with a dose of 8 Gy
Arm Title
Stereotactic radiotherapy 5 x 8 Gy
Arm Type
Experimental
Arm Description
Patient receive 5 stereotactic radiotherapy sessions with a dose of 8 Gy
Arm Title
Stereotactic radiotherapy 4 x 10 Gy
Arm Type
Experimental
Arm Description
Patient receive 4 stereotactic radiotherapy sessions with a dose of 10 Gy
Arm Title
Stereotactic radiotherapy 4 x 12 Gy
Arm Type
Experimental
Arm Description
Patient receive 4 stereotactic radiotherapy sessions with a dose of 12 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy 4 x 8 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy 5 x 8 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy 4 x 10 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy 4 x 12 Gy
Primary Outcome Measure Information:
Title
Occurrence of grade ≥ 4 toxicity
Description
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 .
Time Frame
3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Radiothérapie - Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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Stereotactic Radiotherapy for Renal Cancers

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