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A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Radio-Ablation

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Eligibility Criteria

Patients must have histologically confirmed carcinoma of the kidney
Patients must be able to tolerate extended treatment time 30 minutes for MVCT and treatment delivery) for radiation on the tomotherapy unit
Patients must have confirmed metastatic disease, nodal or locally advanced disease either by biopsy or imaging
Informed consent performed and documented
Patients must have one of a) unresectable local disease, b) be medically inoperable, or c) chosen against having a local surgical treatment
Age ≥ 18
Patients previously received any targeted therapy or immunotherapy for RCC, are also eligible. Patients must be off these agents for a minimum of 2 weeks prior to radiation therapy to be eligible

Exclusion Criteria:

Patients without an adequate functioning contralateral kidney as seen on renal perfusion scan (>40% of total renal flow)
Patients with poor baseline renal function, represented by a creatinine clearance < 50 mL/minute based on the Cockcroft-Gault approximation method
Patients with a creatinine clearance < 50 ml/minute are still eligible if the ipsilateral kidney has <25% of the total renal flow on a renal perfusion scan.

еCCr =140 - (Age) × Mass (in kilograms) × constant Serum creatinine ( in µmol/L) constant = male is 1.23, women is 1.04)

Previous abdominal radiotherapy
Bilateral RCC
Diagnosis of transitional cell carcinoma, squamous cell carcinoma, or a non epithelial cancer of the kidney
Diagnosis of any other malignancy in previous 5 years, excluding non-melanoma skin cancer -Known active malignancy other than RCC, excluding non-melanoma skin cancer
Estimated (by treating radiation oncologist) life expectancy of less than 8 weeks
Pregnant or breast-feeding women
Concurrent illness in addition to RCC that would make radiotherapy delivery unduly challenging, including but not limited to, severe congestive heart failure or other cardiorespiratory conditions, severe neuromuscular disorders, ongoing or active infections, and psychiatric illness
Medical conditions for which radiation is contraindicated, including but not limited to, scleroderma, systemic lupus erythematosus and ataxia teleangiectasia - Patients with excessive kidney motion on pre-planning 4D-CT scan that would prevent safe delivery of radiotherapy with gated or non-gated techniques
Patients taking concurrent medication that can interfere with the safe delivery of radiation (e.g. radiosensitizers)
Urology opinion recommends partial nephrectomy as cytoreductive atment --Expected TKI therapy to be initiated during initial 2 weeks completion of radiotherapy.

Sites / Locations

London Regional Cancer Program of the Laswon Research Health Institue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Radiation: Radio-Ablation

Outcomes

Primary Outcome Measures

evaluate the safety/toxicity profile of renal radio-ablation in the setting of metastatic RCC

toxicity will be assessed using CTCAE v3

Secondary Outcome Measures

Renal Function post renal radio-ablation

BUN, Creatinine

Full Information

NCT ID

NCT02264548

First Posted

July 22, 2014

Last Updated

March 7, 2023

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02264548

Brief Title

A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy

Official Title

A Phase I Study Evaluating the Integration of Hypofractionated Renal Ablative Radiotherapy in the Setting of Metastatic Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 4, 2020 (Actual)

Study Completion Date

August 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

evaluate the safety and toxicity profile of renal radio-ablation in the setting of metastatic renal cell carcinoma. to assess renal function post radio-ablation Primary and metastatic tumour response to radio-ablation

Detailed Description

A dose limiting toxicity (DLT) will be defined as any grade 3, 4 or 5 toxicity event that is considered to be definitely, probably or possibility related to the protocol radiation therapy. Patients that cannot complete protocol therapy due to acute radiation side-effects will also be considered to be a DLT. The general (non-exhausive) list of organ based toxicity that could be related to this type of radiation therapy include toxicity to the liver, kidney, bowel, spinal cord, and pancreas. Side-effects that are exclusively due to TKI targeted therapy are not considered to be DLT in this protocol. Three patients will be recruited for the first cohort of the trial. These patients will have the PTV prescribed a dose of 25 Gray to be given in 5 daily fractions over a period of one week (first treatment to start on a Wednesday or Thursday, with planned treatment on successive business days). All therapy should be delivered within 10 business days including any treatment breaks for acute toxicity. After 3 patients have been seen at the 4 week follow up visit, CTCAE version three will be noted. If precisely 1 patient has a DLT, then an additional 3 patients will be recruited to the same cohort and given the same treatment. If no patient has DLT, then a new cohort of 3 patients will be treated to an increased dose of 30 Gray in 5 fractions. Similar criteria will dictate whether the trial ends, or continues with the next cohort being treated to a dose of 35 Gray in 5 daily fractions. There will be a maximum of 4 cohorts (25Gy, 30Gy, 35Gy, and 40Gy) in this study assuming no early DLT issues, each containing 3 or 6 patients. Allowance for a -1 cohort arm of 20 Gy in 5 fractions is made in this protocol for early DLT issues. The diagram below displays the schema in more detail. Any patient that does not complete protocol therapy due to toxicity issues or is unavailable for the 4-week toxicity assessment is considered to be non-evaluable. These patients will need to be replaced in terms of study accrual. Patients are not to be given TKI therapy during the 4 week window post-RT in order to allow for proper evaluation of the RT intervention; however, the treating oncologist ultimately can override this if it is in the best medical interest of the patient (e.g. progressive and symptomatic systemic disease)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Radiation: Radio-Ablation

Intervention Type

Radiation

Intervention Name(s)

Radio-Ablation

Intervention Description

Level I 20Gy/5 Level II 25Gy/5 Level III 30Gy/5 Level IV 35Gy/5 Level V 40Gy/5

Primary Outcome Measure Information:

Title

evaluate the safety/toxicity profile of renal radio-ablation in the setting of metastatic RCC

Description

toxicity will be assessed using CTCAE v3

Time Frame

After 3 patients have been seen at the 4 week follow up visit,

Secondary Outcome Measure Information:

Title

Renal Function post renal radio-ablation

Description

BUN, Creatinine

Time Frame

4,8,12 wk and every 6months x 5yr

Other Pre-specified Outcome Measures:

Title

Tumour Response

Description

CT abdomen evaluting primary disease using RECIST criteria

Time Frame

4,8,12 wk and every 6 months x5yr.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligibility Criteria Patients must have histologically confirmed carcinoma of the kidney Patients must be able to tolerate extended treatment time 30 minutes for MVCT and treatment delivery) for radiation on the tomotherapy unit Patients must have confirmed metastatic disease, nodal or locally advanced disease either by biopsy or imaging Informed consent performed and documented Patients must have one of a) unresectable local disease, b) be medically inoperable, or c) chosen against having a local surgical treatment Age ≥ 18 Patients previously received any targeted therapy or immunotherapy for RCC, are also eligible. Patients must be off these agents for a minimum of 2 weeks prior to radiation therapy to be eligible Exclusion Criteria: Patients without an adequate functioning contralateral kidney as seen on renal perfusion scan (>40% of total renal flow) Patients with poor baseline renal function, represented by a creatinine clearance < 50 mL/minute based on the Cockcroft-Gault approximation method Patients with a creatinine clearance < 50 ml/minute are still eligible if the ipsilateral kidney has <25% of the total renal flow on a renal perfusion scan. еCCr =140 - (Age) × Mass (in kilograms) × constant Serum creatinine ( in µmol/L) constant = male is 1.23, women is 1.04) Previous abdominal radiotherapy Bilateral RCC Diagnosis of transitional cell carcinoma, squamous cell carcinoma, or a non epithelial cancer of the kidney Diagnosis of any other malignancy in previous 5 years, excluding non-melanoma skin cancer -Known active malignancy other than RCC, excluding non-melanoma skin cancer Estimated (by treating radiation oncologist) life expectancy of less than 8 weeks Pregnant or breast-feeding women Concurrent illness in addition to RCC that would make radiotherapy delivery unduly challenging, including but not limited to, severe congestive heart failure or other cardiorespiratory conditions, severe neuromuscular disorders, ongoing or active infections, and psychiatric illness Medical conditions for which radiation is contraindicated, including but not limited to, scleroderma, systemic lupus erythematosus and ataxia teleangiectasia - Patients with excessive kidney motion on pre-planning 4D-CT scan that would prevent safe delivery of radiotherapy with gated or non-gated techniques Patients taking concurrent medication that can interfere with the safe delivery of radiation (e.g. radiosensitizers) Urology opinion recommends partial nephrectomy as cytoreductive atment --Expected TKI therapy to be initiated during initial 2 weeks completion of radiotherapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Belal Ahmad, MD FRCPC

Organizational Affiliation

London Regional Cancer Program of the Lawson Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Regional Cancer Program of the Laswon Research Health Institue

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

29558966

Citation

Correa RJM, Ahmad B, Warner A, Johnson C, MacKenzie MJ, Pautler SE, Bauman GS, Rodrigues GB, Louie AV. A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma. Radiat Oncol. 2018 Mar 20;13(1):47. doi: 10.1186/s13014-018-0992-3.

Results Reference

derived

PubMed Identifier

27635623

Citation

Correa RJM, Rodrigues GB, Chen H, Warner A, Ahmad B, Louie AV. Stereotactic Ablative Radiotherapy (SABR) for Large Renal Tumors: A Retrospective Case Series Evaluating Clinical Outcomes, Toxicity, and Technical Considerations. Am J Clin Oncol. 2018 Jun;41(6):568-575. doi: 10.1097/COC.0000000000000329.

Results Reference

derived

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A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy

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