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Renal Cell CarcinomaPhase 1NCT02264548

A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy

A Phase 1 study testing Radio-Ablation in people with Renal Cell Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Radio-Ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteCanada
Study dates
Jul 2009to 4 Aug 2020
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Regional Cancer Program of the Laswon Research Health Institue

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

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

  • 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
Read the 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)

Being tested
Radio-Ablation
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radio-AblationRadiation

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

Study groups in NCT02264548
Study groupRoleWhat they receive
Arm 1ExperimentalRadiation: Radio-Ablation
Receives: Radiation: Radio-Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    toxicity will be assessed using CTCAE v3

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

Secondary outcomes (1)

  1. Renal Function post renal radio-ablation

    BUN, Creatinine

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startJul 2009
  3. Primary completion4 Aug 2020
  4. Study completion4 Aug 2020

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264548
Sponsor's protocol ID
Renal Ablation
Status last verified
Mar 2023
First submitted
22 Jul 2014
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29558966

  • 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.

    PubMed 27635623

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radio-Ablation in people with Renal Cell Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

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 8 inclusion and 14 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

evaluate the safety/toxicity profile of renal radio-ablation in the setting of metastatic RCC (time frame: After 3 patients have been seen at the 4 week follow up visit,). 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 NCT02264548, which also lists 2 linked publications.

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 9 Mar 2023.

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