A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy

NCT02264548 | Completed Phase 1 DMC

• 1 other identifier: Renal Ablation
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  toxicity will be assessed using CTCAE v3

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

Secondary Outcomes (1)

• Renal Function post renal radio-ablation

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

Other Outcomes (1)

• Tumour Response

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

Study Arms (1)

Arm 1

EXPERIMENTAL

Radiation: Radio-Ablation

Radiation: Radio-Ablation

Interventions

Radio-Ablation RADIATION

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Regional Cancer Program of the Laswon Research Health Institue

London, Ontario, N6A 4L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 29558966 DERIVED

• 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.

  PMID: 27635623 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Belal Ahmad, MD FRCPC

  London Regional Cancer Program of the Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: October 15, 2014
• Study Start: July 1, 2009
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

CA (1)