Status:
COMPLETED
A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 res...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02264548
Start Date
July 1 2009
End Date
August 4 2020
Last Update
March 9 2023
Active Locations (1)
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1
London Regional Cancer Program of the Laswon Research Health Institue
London, Ontario, Canada, N6A 4L6