Last updated: March 7, 2023
Sponsor: Lawson Health Research Institute
Overall Status: Completed
Phase
1
Condition
Carcinoma
Kidney Cancer
Renal Cell Carcinoma
Treatment
N/AClinical Study ID
NCT02264548
Renal Ablation
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andtreatment delivery) for radiation on the tomotherapy unit
- Patients must have confirmed metastatic disease, nodal or locally advanced diseaseeither 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 alsoeligible. Patients must be off these agents for a minimum of 2 weeks prior toradiation therapy to be eligible
Exclusion
Exclusion Criteria:
- Patients without an adequate functioning contralateral kidney as seen on renalperfusion scan (>40% of total renal flow)
- Patients with poor baseline renal function, represented by a creatinine clearance < 50mL/minute based on the Cockcroft-Gault approximation method
- Patients with a creatinine clearance < 50 ml/minute are still eligible if theipsilateral kidney has <25% of the total renal flow on a renal perfusion scan. × 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 epithelialcancer of the kidney
- Diagnosis of any other malignancy in previous 5 years, excluding non-melanoma skincancer -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 undulychallenging, including but not limited to, severe congestive heart failure or othercardiorespiratory conditions, severe neuromuscular disorders, ongoing or activeinfections, and psychiatric illness
- Medical conditions for which radiation is contraindicated, including but not limitedto, scleroderma, systemic lupus erythematosus and ataxia teleangiectasia - Patientswith excessive kidney motion on pre-planning 4D-CT scan that would prevent safedelivery of radiotherapy with gated or non-gated techniques
- Patients taking concurrent medication that can interfere with the safe delivery ofradiation (e.g. radiosensitizers)
- Urology opinion recommends partial nephrectomy as cytoreductive atment --Expected TKItherapy to be initiated during initial 2 weeks completion of radiotherapy.
Study Design
Total Participants: 14
Study Start date:
July 01, 2009
Estimated Completion Date:
August 04, 2020
Study Description
Connect with a study center
London Regional Cancer Program of the Laswon Research Health Institue
London, Ontario N6A 4L6
CanadaSite Not Available
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