Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02019576 : Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02019576      |      Link to official Clinicaltrials.gov listing
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