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Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02019576
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : March 23, 2021
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:

Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely and accurately delivers high dose radiation to a tumour, while sparing much of the nearby normal organs. The use of stereotactic radiotherapy results in high rates of tumour destruction with minimal side effects which are very well tolerated. Often stereotactic radiotherapy has been used to try to cure patients who have an early stage cancer which has not spread, but there is less experience with using it in patients with cancer which has spread.

The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney cancer tumours which are no longer being controlled by Sunitinib and to measure how much longer such an approach will allow patients to stay on Sunitinib before needing to switch to another medication. Stereotactic radiotherapy will be used to treat only the growing tumours and then patients will continue with Sunitinib.

Condition or disease Intervention/treatment Phase
Clear Cell Metastatic Renal Cell Carcinoma Radiation: Stereotactic radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A Phase II study, single arm study, open-label, safety and efficacy study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Metastatic Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy
Study Start Date : May 2014
Actual Primary Completion Date : February 16, 2021
Actual Study Completion Date : March 4, 2021

Arm Intervention/treatment
Stereotactic radiotherapy (SRT)
Stereotactic radiotherapy will be administered for up to five areas of metastatic sites showing oligo-progression within the same time period. During the Sunitinib break period, stereotactic radiotherapy will be delivered in a single fraction or up to a maximum of eight fractions. The number of fractions will depend on how many sites are being irradiated.
Radiation: Stereotactic radiotherapy
SRT to all areas of oligo-progression as follows: BRAIN: 20-24 Gy in 1 fraction if < 2 cm,18 Gy in 1 fraction if 2-3 cm,15 Gy in 1 fraction for 3-4 cm, alternatively 25-30 Gy in 5 fractions can be used; SPINE: 18-24 Gy in 1-2 fractions,24 Gy in 3 fractions or 30-40 Gy in 5 fractions; NON-SPINE BONE: 30-40 Gy in 5 fractions; LUNG: 48-60 Gy in 4 fractions or 54-60 Gy in 3 fractions for peripheral lung tumours,50 Gy in 5 fractions or 60 Gy in 8 fractions for central lung tumours; LIVER: 30-60 Gy in 3-6 fractions,higher doses for central liver lesions and lower doses for peripheral liver lesions depending on proximity to adjacent organ (stomach, small bowel, large bowel or kidney); ADRENAL OR KIDNEY TUMOURS: 30-40 Gy in 5 fractions; LYMPHADENOPATHY: 30-40 Gy in 5 fractions.
Other Name: SRT

Primary Outcome Measures :
  1. To evaluate local control at one year of metastases treated with stereotactic radiotherapy in patients who present with oligo-progression while receiving first-line treatment with Sunitinib. [ Time Frame: 3 years ]
    Patients will have evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. All progressing metastases sites will be amenable to stereotactic radiotherapy. The primary endpoint of local control will be defined as the absence of local failure in the irradiated site(s). Progressive enlargement will be defined as a 20% enlargement observed on two consecutive scans from baseline scan.

Secondary Outcome Measures :
  1. To evaluate progression free survival after stereotactic radiotherapy while continuing to receive first-line systemic therapy with Sunitinib. [ Time Frame: 3 years ]
    Progression free survival will be evaluated via disease assessments of radiology scans completed every three months from the time of stereotactic radiotherapy until progression is confirmed. Progressive disease will be defined as a 20% increase in RECIST 1.1 criteria measurements observed on two consecutive scans from the baseline scan.

  2. To evaluate the acute and late toxicity to stereotactic radiotherapy. [ Time Frame: 3 years ]
    Acute and late toxicities to stereotactic radiotherapy will be assessed from adverse events, vital signs and by clinically significant changes in laboratory evaluations. Adverse events will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. These events will be followed until resolution or for a maximum of two years, which ever occurs first.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Able and willing to provide written informed consent and to comply with the study procedures.
  3. Karnofsky performance status of ≥ 80%.
  4. Favorable or intermediate Heng prognostic group defined as having two or less of the following factors: hemoglobin < LLN; serum corrected calcium > ULN; Karnofsky performance status < 80%; time from initial diagnosis to initiation of therapy < 1 year; absolute neutrophil count > ULN; platelet count > ULN.
  5. Histologic confirmation of renal cell carcinoma with a clear cell component.
  6. Evidence of measurable disease according to RECIST 1.1 criteria.
  7. Already receiving first-line sunitinib therapy for at least 3 months with at least one imaging compared to baseline (or a CT from one year prior to the date of registration for patients that have been on Sunitinib therapy for over one year) that shows response or stable disease per RECIST v1.1, in all metastatic lesions (Note: SD by RECIST that allows ≤ 19% increase is allowed). Prior immunotherapy including interferon, IL-2, and checkpoint inhibitors is allowed before Sutent.
  8. Radiographic evidence of ≤ 5 metastatic lesions progressing. Of the 5 progressing lesions, a maximum of 3 lesions can be in soft tissue. (Ex. If no bone metastases progressing: a maximum of 3 soft tissue lesions. If bone metastases progressing: a maximum of 5 total lesions and a maximum of 3 in soft tissue.)
  9. All progressing metastases are amenable to stereotactic radiotherapy.
  10. Each progression metastases fulfills at least 1 of the 3 following criteria for oligo-progression: a. Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during first line systemic therapy and associated with a 5 mm minimum increase in size); b. Unambiguous development of a new metastatic lesion from the time of scan taken prior to starting first-line therapy with sunitinib; c. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart, while receiving first-line therapy with sunitinib, with a minimum 5 mm increase in size from baseline.

Exclusion Criteria:

  1. Evidence of spinal cord compression.
  2. Inability to safely treat all sites of progressing metastases.
  3. Prior malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
  4. Concurrent administration of other anti-cancer therapy apart from first-line sunitinib.
  5. Diagnosis of ataxia telangiectasia or active collagen vascular disease.
  6. Other condition, illness, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or stereotactic radiotherapy administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02019576

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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Manitoba CancerCare Institute
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Principal Investigator: Georg A. Bjarnason, MD, FRCPC Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: Patrick Cheung, MD, FRCPC Toronto Sunnybrook Regional Cancer Centre
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Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT02019576    
Other Study ID Numbers: OZM-053
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Keywords provided by Sunnybrook Health Sciences Centre:
Metastatic renal cell carcinoma
Clear cell
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases