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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02334709 |
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Date of registration:
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06/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.
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Scientific title:
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Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect. |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02334709 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Piet Ost, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Radiotherapy, Ghent University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- signed informed consent
- diagnosis of RCC with clear-cell component histology
- at least 3 extracranial measurable metastatic lesions per RECIST
- Karnofsky Performance score >60
- patients should have undergone cytoreductive treatment of their RCC at least 6 weeks
prior to inclusion
- patients should have adequate organ function for TKI treatment.
Exclusion Criteria:
- prior systemic treatment for RCC
- uncontrolled central nervous metastases
- prior radiotherapy interfering with SBRT
- any disorder precluding understanding of trial information.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carcinoma, Renal Cell
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Intervention(s)
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Radiation: Stereotactic body radiotherapy
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Primary Outcome(s)
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Dose limiting toxicity
[Time Frame: 2 years]
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Secondary Outcome(s)
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Response rate
[Time Frame: 4 years]
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Immunomonitoring
[Time Frame: 4 years]
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Secondary ID(s)
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EC/2013/1087
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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